Biopsy assembly

Abstract

A biopsy assembly for taking a biopsy in human or animal tissue, the biopsy assembly comprising: - a needle assembly (3) comprising an elongated inner needle portion (5) and an elongated outer needle portion (7), the outer needle portion (7) being a hollow part, the inner needle portion (5) being coaxially fitted therein, wherein the two needle portions can be set in at least two different positions relative to each other; - an actuator (11) arranged in the biopsy assembly (1) such that it can move within the biopsy assembly, the actuator (11) comprising: - a first actuation portion (13) configured to control a needle locking device (21) provided in the biopsy assembly (1) to lock or not lock the inner needle portion (5) and the outer needle portion (7) to each other; and - a second actuation portion (15) configured to control a needle translation device (31) provided in the biopsy assembly (1) to change the position of the inner needle portion (5) and the outer needle portion (7) relative to each other, the needle translation device (31) being connected to at least one of the inner needle portion (5) or the outer needle portion (7), whereby the movement of the actuator (11) within the biopsy assembly (1) can influence the position of both the first actuation portion (13) and the second actuation portion (15), whereby both the needle locking device (21) and the needle translation device (31) can be controlled.

Description

Technical Field

[0001] This invention relates to a biopsy assembly for obtaining biopsies from human or animal tissues. Background Technology

[0002] Today, it is generally accepted that a definitive diagnosis of a suspected malignant lesion must be confirmed using biopsy techniques. The most commonly performed cell and tissue sampling techniques include fine-needle aspiration (FNA), primarily using 22G and 23G needles (0.6–0.7 mm in diameter), and core-needle biopsy (CNB) or vacuum-assisted biopsy (VAB) using needles of any size between 8G and 18G (1.3–4.2 mm in diameter), with the latter two techniques being the most dominant globally. Due to the significantly improved sensitivity and minimal invasiveness resulting from combining needle biopsy techniques with imaging guidance, the number of open surgical biopsies is steadily declining.

[0003] Compared to FNA, CNB and VAB allow for extensive tissue sampling, which enables the differentiation of in situ and invasive lesions, histological diagnosis of microcalcifications, and analysis of several relevant biomarkers.

[0004] Significant advances have been made in visualization techniques, constantly pushing the boundaries of possible methods for locating suspicious lesions. Furthermore, numerous developments, such as the use of advanced biomarkers for follow-up and personalized adjunctive therapy, have defined new requirements for highly precise and minimally invasive tissue sampling.

[0005] The biopsy needles used in most CNB and VAB devices have a sharp, solid distal end, which is necessary for penetrating tissue toward the site from which the biopsy is to be taken. To penetrate a suspicious lesion, the needle must be inserted manually or using a commonly used spring-loaded mechanism to advance the needle into the lesion to a predetermined length. This is followed by initiating a tissue sampling procedure, which typically involves opening a residual space that fills with surrounding tissue and is subsequently closed, thereby cutting the tissue within the residual space from the surrounding tissue.

[0006] The opening and possible closing of the remaining space is typically accomplished by the relative movement of two separate elements of the needle biopsy assembly, such as the inner sampling needle relative to the outer cutting needle, the inner cannula needle relative to the outer sampling needle, or the distal cutting blade relative to the distal end sampling needle.

[0007] Different types of biopsy devices are well known in the art. Some documents describing biopsy devices with a hollow needle and an elongated rod include WO 0056220, EP 2520237, US 2012 / 0029354, US 5188118, US 5348022, US 5121751, US 6120463, US 8282573, US 7828748, WO 2014 / 007380, DE 20211934U, US8313444, and US 5392790. A core biopsy assembly has been described by the applicant in EP 2323563, in which reciprocating longitudinal movement is applied to the biopsy needle. In EP 3206587 and WO 2016 / 058845, the applicant discloses a biopsy assembly that utilizes the reciprocating longitudinal movement of a biopsy needle, wherein specific details are described regarding the needle construction, including an inner cannula, and the specific construction of the distal end of the needle for cutting the sample. Furthermore, the following documents describe biopsy assemblies including blades or cutting components: WO 2012015801, EP 1832234, WO 0010465, US 5615690, RU2212848, US 2009012423, and WO 2008115526.

[0008] Furthermore, manually inserting a large-diameter needle through healthy tissue toward a target lesion can be cumbersome, especially if the tissue is dense or fibrotic. The physician must exert force to guide the sharp needle toward the lesion while maintaining dexterity and control to avoid damaging blood vessels and organs. The insertion process is a source of patient anxiety and therefore should be as short and efficient as possible. Summary of the Invention

[0009] The purpose of this invention is to provide an improved biopsy assembly.

[0010] This is achieved by the biopsy component according to claim 1.

[0011] According to one aspect of the present invention, a biopsy assembly is provided for obtaining biopsies in human or animal tissues, the biopsy assembly comprising:

[0012] - A needle assembly comprising an elongated inner needle portion and an elongated outer needle portion, the outer needle portion being a hollow component therein, wherein the inner needle portion is coaxially fitted therein, wherein the two needle portions may be positioned at at least two different locations relative to each other;

[0013] - An actuator disposed within the biopsy assembly such that it is movable within the biopsy assembly, the actuator comprising:

[0014] - The first actuating part is configured to control a needle locking device located in the biopsy assembly to lock or delock the inner needle portion and the outer needle portion to each other; and

[0015] - A second actuation part configured to control a needle translation device disposed in the biopsy assembly to change the position of the inner needle portion and the outer needle portion relative to each other, the needle translation device being connected to at least one of the inner needle portion or the outer needle portion.

[0016] Thus, the movement of the actuator within the biopsy assembly can affect the positions of both the first and second actuation parts, thereby controlling both the needle locking device and the needle translation device.

[0017] Therefore, a biopsy assembly is provided that, for example, during insertion of the needle assembly to the sampling position, locks the inner and outer needle portions together and then releases the lock on the needle portions for a sampling procedure. An actuator is disposed in the biopsy assembly, and according to the invention, movement of the actuator can affect both the locking or releasing of the needle portions relative to each other and the position of the needle portions relative to each other, i.e., the execution of the sampling procedure. Thus, during insertion to the sample position, the needle portions can be suitably held locked together, and the actuator is moved to first release the lock between the needle portions and then change the position of the inner and outer needle portions relative to each other to obtain a sample. For example, in a so-called core needle biopsy, the outer needle portion retracts first, while the inner needle portion includes a sample receiving groove, which is then filled, and the sample in the sample receiving groove is then cut from the tissue as the outer needle portion moves forward again. It is advantageous to perform these steps by moving only the actuator. Therefore, it is possible, for example, to move the actuator only linearly and thus perform both the release of the needle lock and sampling by a single linear movement. Therefore, due to the single linear movement, simple and effective electromechanical control for controlling sampling can be provided. Thus, a biopsy assembly that is easily operable by the user can be provided. Furthermore, the possibility of locking the needle portions together during needle positioning is suitable, and reciprocating pulses can be provided to the locked needle assembly, which is advantageous for needle insertion and positioning. Moreover, the movement of the actuator can be easily actuated by a motor, and the movement of the actuator can be easily controlled in different steps, thereby allowing the user to control the sampling process. Using the biopsy assembly according to the invention, the needle can be inserted into the correct position in the locked state, and possibly with increased reciprocating pulses. The position can be adjusted and verified, and then the sampling procedure is performed. Therefore, the chance of obtaining large and representative samples is improved.

[0018] In one embodiment of the invention, the biopsy assembly further includes a release device configured to release the connection between a second actuation portion of the actuator and a needle translation device when the actuator is moved to a certain position, thereby allowing movement of the actuator within the biopsy assembly to control at least three different functions, including controlling a needle locking device to lock or delock the inner and outer needle portions to each other, controlling the position of the inner and outer needle portions relative to each other, and releasing the connection between the second actuation portion and the needle translation device.

[0019] In one embodiment of the invention, an actuator is arranged within the biopsy assembly such that it can move linearly in one direction within the biopsy assembly to control at least three different functions. Thus, it is possible to perform both needle locking release and sampling via a single linear movement. Due to this single linear movement, simple and efficient electromechanical control for controlling sampling can be provided. Therefore, a biopsy assembly that is easily operable by the user can be provided.

[0020] In one embodiment of the invention, the needle translation device includes an elastic element that, if the inner or outer needle portion is moved, will attempt to return the inner or outer needle portion to its original position.

[0021] In one embodiment of the invention, the release device is positioned within the biopsy assembly such that when the needle translation device is moved a certain distance within the biopsy assembly by the second actuation portion, the release device will release the connection between the second actuation portion and the needle translation device, and thus the elastic element is loaded and will be released when the needle translation device is released from the second actuation portion.

[0022] In one embodiment of the invention, the inner needle portion includes a sample receiving groove along its length, wherein the outer needle portion may be disposed at at least a first outer needle portion position and a second outer needle position, wherein at the first outer needle portion position the outer needle portion covers the sample receiving groove, and at the second outer needle position the outer needle portion is retracted and does not cover the sample receiving groove, the sample receiving groove being open for receiving a sample.

[0023] In one embodiment of the invention, the needle translation device includes an external needle connection member connected to an external needle portion, whereby translation of the needle translation device is transmitted as translation of the external needle portion.

[0024] In one embodiment of the invention, the needle locking device may be provided in at least a first needle locking device state and a second needle locking device state, wherein in the first needle locking device state the needle locking device locks the inner needle portion and the outer needle portion to each other so that they cannot move relative to each other, while in the second needle locking device state the needle locking device does not lock the inner needle portion and the outer needle portion to each other, thereby the first actuating part can affect the state of the needle locking device by the movement of the actuator.

[0025] In one embodiment of the invention, the actuator is configured to be connected to a motor such that the position of the actuator can be controlled by the motor.

[0026] In one embodiment of the invention, the biopsy assembly further includes a pulse device configured to interact with the needle assembly such that reciprocating pulses from the pulse device can be delivered to the needle assembly. Providing reciprocating pulses to the locking needle assembly during insertion is advantageous for needle insertion and positioning. The needle can be inserted into the correct position in the locked state using the increased reciprocating pulses. Position can be adjusted and verified, and then a sampling procedure can be performed.

[0027] In one embodiment of the invention, the biopsy assembly further includes an actuator movement device configured to engage with an actuator and transmit movement to the actuator.

[0028] In one embodiment of the invention, the biopsy assembly includes a reusable driver unit and a disposable sampler, wherein the disposable sampler includes the needle assembly, the needle locking device, the needle translation device, and the actuator, and the driver unit includes an actuator moving device configured to engage with the actuator and transmit movement to the actuator.

[0029] In one embodiment of the present invention, the driver unit further includes a pulse device. Attached Figure Description

[0030] Figures 1a-1d The interior of the sampler of a biopsy assembly according to an embodiment of the present invention is shown at four different sampling locations.

[0031] Figure 2 This is a perspective view of a portion of the actuator and needle translation device according to an embodiment of the present invention.

[0032] Figure 3 This is a top perspective view of a sampler for a biopsy assembly according to an embodiment of the present invention.

[0033] Figure 4 This is a perspective view of the driver unit of a biopsy assembly according to an embodiment of the present invention.

[0034] Figure 5a This is a side view of a biopsy assembly according to an embodiment of the present invention.

[0035] Figure 5b For as in Figure 5a The cross-section of such a biopsy component is shown.

[0036] Figure 6 This is a cross-section of a portion of a biopsy assembly according to an embodiment of the present invention.

[0037] Figure 7 For as in Figure 6 Another cross section of the same biopsy component shown. Detailed Implementation

[0038] Figures 1a-1d The interior of the sampler 50 of a biopsy assembly 1 according to an embodiment of the present invention is shown at four different sampling locations. In this embodiment of the invention, the biopsy assembly 1 includes a reusable driver unit 51 connected during sampling and a disposable sampler 50. The disposable sampler 50 is located in... Figure 3 The image is shown in perspective, and the driver unit is... Figure 4 The image is shown in perspective, and the two parts are in an assembled state. Figure 5a As shown in the figure. However, in another embodiment of the invention, the biopsy component 1 need not be separated into a disposable sampler and a reusable actuator, but can instead be a single unit. Figures 1a-1d In the middle, cover plate 44 has been removed, and some of the interior of biopsy component 1 can be seen.

[0039] A biopsy assembly 1 for obtaining biopsies in human or animal tissues according to the present invention is provided. The biopsy assembly 1 includes a needle assembly 3. The needle assembly 3 can be used in… Figure 5a and Figure 5bAs seen in the figures, it includes an elongated inner needle portion 5 and an elongated outer needle portion 7, the outer needle portion 7 being a hollow component in which the inner needle portion 5 is coaxially fitted. The two needle portions 5, 7 may be positioned relative to each other in at least two different locations. In some embodiments of the invention, although not essential, the inner needle portion 5 includes a sample receiving groove 6, i.e., a side opening for receiving a sample, along its length. The outer needle portion 7 and the inner needle portion 5 are movable relative to each other such that the outer needle portion 7 covers the sample receiving groove 6 in a first needle position and does not cover the sample receiving groove 6 in a second needle position. In embodiments such as those shown in Figures 1-7, the outer needle portion 7 is moved (i.e., retracted) to open the sample receiving groove 6 and then advanced again to cut off the sample within the sample receiving groove. However, in another embodiment, the inner needle portion 5 is moved instead.

[0040] According to the invention, the biopsy assembly 1 further includes an actuator 11 disposed within the biopsy assembly 1 such that it is movable within the biopsy assembly. The actuator 11 includes a first actuation portion 13 configured to control a needle locking device 21 disposed within the biopsy assembly 1 to lock or delock the inner needle portion 5 and the outer needle portion 7 to each other. The actuator also includes a second actuation portion 15 configured to control a needle translation device 31 disposed within the biopsy assembly 1 to change the position of the inner needle portion 5 and the outer needle portion 7 relative to each other. The needle translation device 31 is connected to at least one of the inner needle portion 5 or the outer needle portion 7. Movement of the actuator 11 within the biopsy assembly 1 affects the position of both the first actuation portion 13 and the second actuation portion 15, thereby allowing the needle to control both the locking device 21 and the needle translation device 31 by moving only the actuator 11. Figure 1a In this configuration, the first actuating part 13 is positioned such that it controls the needle locking device 21 to lock the inner needle part 5 and the outer needle part 7 together. Figure 1b In the process, actuator 11 moves a first distance d1, thereby releasing needle locking device 21 from the first actuation part 13, so that needle locking device 21 no longer locks the inner needle part 5 and the outer needle part 7 to each other. When actuator 11 moves the first distance d1, the second actuation part 15 will reach the actuator engagement part 34 of needle translation device 31 (in Figure 2 (As seen in the image). When the actuator 11 is moved further, the needle translation device 31 also moves accordingly. Figure 1c In the middle, the actuator 11 moves backward by a second distance d2, causing the needle translation device 31 to reach the release device 41, which will be further described below. Therefore, the inner needle portion 5 and the outer needle portion 7 are moved relative to each other by the needle translation device 31. Figure 1dIn this process, the needle translation device 31 is released from the actuator 11 by the release device 41, which will be described further below. The elastic element 33 loaded during the retraction of the needle translation device 31 will then cause the needle translation device 31 to return to its original position, and thus the inner needle portion 5 and the outer needle portion 7 return to their initial positions.

[0041] In this embodiment of the invention, the needle translation device 31 includes an external needle connecting member 35 connected to the external needle portion 7, whereby the translation of the needle translation device 31 is transmitted as a translation of the external needle portion 7. However, in another embodiment of the invention, the needle translation device 31 alternatively includes an internal needle connecting member connected to the internal needle portion 5, whereby the translation of the needle translation device 31 is transmitted as a translation of the internal needle portion 5.

[0042] The needle locking device 21 can be configured in at least a first needle locking device state and a second needle locking device state. In the first needle locking device state, the needle locking device 21 locks the inner needle portion 5 and the outer needle portion 7 to each other, preventing them from moving relative to each other. In the second needle locking device state, the needle locking device 21 does not lock the inner needle portion 5 and the outer needle portion 7 to each other. The first actuation portion 13 of the actuator 11 can influence the state of the needle locking device 21 by moving the actuator 11; that is, by moving the actuator 11, the needle locking device 21 can be controlled to lock or not lock the inner needle portion 5 and the outer needle portion 7 to each other. The locking device 21 can be designed in different ways, but in this embodiment, the rear end of the inner needle portion 5 (opposite to the sharp insertion end) includes a sliding region 22 along which the rear end of the outer needle portion 7 can slide. The locking device 21 includes a blocking portion 23 positioned above the sliding region 22, thus preventing the outer needle portion 7 from sliding above the sliding region 22.

[0043] In this embodiment of the invention, the actuator 11 is arranged within the biopsy assembly 1 such that it can move linearly within the biopsy assembly to control at least two different functions (i.e., locking or unlocking the needle portions to each other, and moving the needle portions relative to each other). Thus, these two different functions can be controlled by moving the actuator 11 only linearly. Therefore, the actuator 11 can be easily connected to a motor, for example via the actuator moving device 53a (as will be described below), so that the position of the actuator 11 can be controlled by the motor. In another embodiment of the invention, the movement of the actuator 11 within the biopsy assembly 1 does not need to be linear, but can instead be rotational movement. Such rotational movement can also be easily controlled by a motor.

[0044] In an embodiment of the invention as shown in Figures 1-2, the biopsy assembly 1 further includes a release device 41 configured to release the connection between the second actuation portion 15 of the actuator 11 and the needle translation device 31 when the actuator 11 is moved to a certain position. Therefore, the movement of the actuator 11 within the biopsy assembly 1 (potentially a linear movement as shown in Figures 1-2) can control at least three different functions, including controlling the needle locking device 21 to lock or unlock the inner needle portion 5 and the outer needle portion 7 to each other, controlling the position of the inner needle portion 5 and the outer needle portion 7 relative to each other, and releasing the connection between the second actuation portion 15 and the needle translation device 31. Figure 2 The release device 41 is best seen in the center.

[0045] As in Figures 1a-1d As shown, the needle translation device 31 suitably includes an elastic element 33 that, if the inner needle portion 5 or the outer needle portion 7 is moved, will attempt to return the inner needle portion 5 or the outer needle portion 7 to its original position. A release device 41 is positioned within the biopsy assembly 1 such that when the needle translation device 31 is moved a second distance d2 within the biopsy assembly 1 by the second actuation portion 15, the release device 41 will release the connection between the second actuation portion 15 and the needle translation device 31, and thus the elastic element 33 is loaded and will be released when the needle translation device 31 is released from the second actuation portion 15. The elastic element 33 may be, for example, a spring loaded when compressed. A spring holding device 133 may be provided within the biopsy assembly 1 to retain and load the spring 33 during movement of the needle translation device 31. The release device 41 may be provided with a first inclined surface 42, which reacts to a second inclined surface 32 of the needle translation device 31, such that when the needle translation device 31 moves to a position where the first and second inclined surfaces 42 meet, the first inclined surface 42 guides the second inclined surface 32, causing the needle translation device 31 to begin partially moving in a new direction. The actuator engagement portion 34 of the needle translation device 31 will thus slide over the shoulder 15a of the second actuation portion 15, releasing the needle translation device 31 from the actuator 11. The elastic element 33 will then force the needle translation device 31 back to its original position, and thus, the outer needle portion 5 and the inner needle portion 7 are also transferred back to their original positions.

[0046] Using this invention, at least two different functions (i.e., locking or unlocking the needle portions to each other, and moving the needle portions relative to each other) can be performed by moving the actuator in a single linear movement (i.e., only in one direction rather than back and forth). In an embodiment as shown in Figures 1-7, the needle portions first unlock from each other, and then the outer needle portion retracts by moving the actuator linearly in only one direction. Furthermore, in this embodiment, a third function is also controlled by the same linear movement of the actuator in the same direction. This releases the connection between the second actuation portion 15 of the actuator and the needle translation device.

[0047] Therefore, in some embodiments of the invention, the inner needle portion 5 can be held in the same position throughout the sampling procedure, while the outer needle portion 7 is first retracted by an actuator acting on the needle translation device 31, and then advanced by force from the elastic element 33. This is advantageous because the two needle portions can first be connected to each other and positioned in the optimal sampling position, and then the inner needle portion is held in that position during sampling, while only the outer needle portion moves. Thus, sampling accuracy can be improved.

[0048] Furthermore, in some embodiments, the biopsy assembly includes a pulse device 61 configured to interact with the needle assembly 3, such that reciprocating pulses from the pulse device 61 can be delivered to the needle assembly 3. If the biopsy assembly 1 is divided into two parts (i.e., a driver unit 51 and a disposable sampler 50, as described above), the pulse device 61 may be located in the driver unit 51 of the biopsy assembly 1. The driver unit 51 may be located in... Figure 4 As seen in, and in Figure 7 The pulse device 61 is best viewed in the image. The pulse device 61 includes a needle interaction portion 63 that contacts the pulse transmission portion 65 of the needle assembly 3. Therefore, reciprocating movement of the pulse device 61 can be transmitted to the needle assembly 3, causing the needle assembly to pulsate, for example, during insertion of the needle assembly 3 to the position where a sample should be obtained. Thus, the pulsation facilitates and improves the cutting and positioning of the needle through dense tissue, and consequently makes the sampling procedure more convenient for the patient.

[0049] The driver unit 51 can be connected to the base unit (not shown). The base unit can supply power to the driver unit 51 and may also provide vacuum and pressurized air. Alternatively, the driver unit 51 can be directly connected to a power outlet without the need for an intermediate base unit. Both the actuator 11 and the pulse supply to the pulse device 61 require power.

[0050] The pulse device 61 may be a piston assembly. Such a piston assembly includes a piston arranged to reciprocate within a piston housing. This piston assembly is driven by a motion-generating source (not shown), such as a weight accelerated by pressurized air generated by a compressor. This motion-generating source may be located in a driver unit 51 or in a base unit to which the driver unit is connected. Alternatively, the piston assembly may be driven by a force generated by magnetism, hydraulic pressure, or a spring. In another alternative, the piston assembly may be driven by a force generated by an electric motor or a piezoelectric device. Details of a pulse device also applicable to this invention are described in EP 2323563, EP3206587, and WO 2016 / 058845.

[0051] Furthermore, the biopsy assembly 1 includes an actuator moving device 53a, which includes an actuator engagement portion 53b configured to engage with a translational position 54 of the actuator 11. Therefore, the actuator 11 can be moved by moving the actuator moving device 53a. The actuator moving device 53a can be moved linearly, for example, by a connected motor.

[0052] As briefly discussed above, in some embodiments of the invention, the biopsy assembly 1 may include a reusable actuator unit 51 and a disposable sampler 50, which may be connected to each other during use of the biopsy assembly. The disposable sampler 50 includes the needle assembly 3, the needle locking device 21, the needle translation device 31, and the actuator 11, while the actuator unit 51 includes an actuator movement device 53a. The actuator unit 51 may also include a pulse device 61.

Claims

1. A biopsy assembly for obtaining biopsies from human or animal tissue, the biopsy assembly comprising: - A needle assembly (3) comprising an elongated inner needle portion (5) and an elongated outer needle portion (7), the outer needle portion (7) being a hollow component, wherein the inner needle portion (5) is coaxially fitted therein, wherein the two needle portions are capable of being positioned at at least two different locations relative to each other; - An actuator (11) disposed in the biopsy assembly (1) such that it is movable within the biopsy assembly, the actuator (11) comprising: - A first actuating part (13) configured to control a needle locking device (21) disposed in the biopsy assembly (1) to lock or delock the inner needle part (5) and the outer needle part (7) to each other; and - A second actuating part (15) configured to control a needle translation device (31) disposed in the biopsy assembly (1) to change the position of the inner needle part (5) and the outer needle part (7) relative to each other, the needle translation device (31) being connected to at least one of the inner needle part (5) or the outer needle part (7). Thus, the movement of the actuator (11) within the biopsy assembly (1) can affect the positions of both the first actuation part (13) and the second actuation part (15), thereby controlling both the needle locking device (21) and the needle translation device (31). The biopsy component also includes: - A release device (41) configured to release the connection between the second actuation portion (15) of the actuator (11) and the needle translation device (31) when the actuator (11) moves to a certain position, thereby enabling the movement of the actuator (11) within the biopsy assembly (1) to control at least three different functions, including controlling the needle locking device (21) to lock or delock the inner needle portion (5) and the outer needle portion (7) to each other, controlling the position of the inner needle portion (5) and the outer needle portion (7) relative to each other, and releasing the connection between the second actuation portion (15) and the needle translation device (31); The actuator (11) is arranged within the biopsy assembly (1) such that it can move linearly in one direction within the biopsy assembly to control at least three different functions.

2. The biopsy assembly according to claim 1, characterized in that, The needle translation device (31) includes an elastic element (33) that, if the inner needle portion (5) or the outer needle portion (7) is moved, the elastic element (33) will attempt to return the inner needle portion (5) or the outer needle portion (7) to its original position.

3. The biopsy assembly according to claim 2, characterized in that, The release device (41) is positioned within the biopsy assembly (1) such that when the needle translation device (31) is moved a certain distance within the biopsy assembly (1) by the second actuation part (15), the release device (41) will release the connection between the second actuation part (15) and the needle translation device (31), and thus the elastic element (33) is loaded and will be released when the needle translation device (31) is released from the second actuation part (15).

4. The biopsy assembly according to any one of the preceding claims, characterized in that, The inner needle portion (5) includes a sample receiving groove (6) along its length, wherein the outer needle portion (7) is capable of being disposed at at least a first outer needle portion position and a second outer needle position, wherein at the first outer needle portion position, the outer needle portion (7) covers the sample receiving groove (6), and at the second outer needle position, the outer needle portion (7) is retracted and does not cover the sample receiving groove (6), wherein the sample receiving groove (6) is open for receiving a sample.

5. The biopsy assembly according to any one of the preceding claims, characterized in that, The needle translation device (31) includes an external needle connection member (35) connected to the external needle portion (7), whereby the translation of the needle translation device (31) is transmitted as the translation of the external needle portion (7).

6. The biopsy assembly according to any one of the preceding claims, characterized in that, The needle locking device (21) can be configured in at least a first needle locking device state and a second needle locking device state, wherein in the first needle locking device state the needle locking device (21) locks the inner needle portion (5) and the outer needle portion (7) to each other so that they cannot move relative to each other, while in the second needle locking device state the needle locking device (21) does not lock the inner needle portion (5) and the outer needle portion (7) to each other, thereby the first actuating part (13) can affect the state of the needle locking device (21) by the movement of the actuator (11).

7. The biopsy assembly according to any one of the preceding claims, characterized in that, The actuator (11) is configured to be connected to a motor, such that the position of the actuator (11) can be controlled by the motor.

8. The biopsy assembly according to any one of the preceding claims, characterized in that, The biopsy assembly also includes a pulse device (61) configured to interact with the needle assembly (3) such that reciprocating pulses from the pulse device (61) can be transmitted to the needle assembly (3).

9. The biopsy assembly according to any one of the preceding claims, characterized in that, The biopsy assembly also includes an actuator moving device (53a) configured to engage with the actuator (11) and transmit movement to the actuator (11).

10. The biopsy assembly according to any one of the preceding claims, characterized in that, The biopsy assembly includes a reusable actuator unit (51) and a disposable sampler (50), wherein the disposable sampler (50) includes the needle assembly (3), the needle locking device (21), the needle translation device (31), and the actuator (11), and the actuator unit (51) includes an actuator moving device (53a) configured to engage with the actuator (11) and transmit movement to the actuator (11).

Images