Biopsy Device

Abstract

The biopsy needle device (20) comprises a needle sheath (22) and a needle (21). The biopsy needle device is configured to be operatively connected to an actuator device (30) configured to push the needle and sheath in a distal sliding direction x. The biopsy needle device further comprises a needle connector (370) configured to attach the needle to the actuator device and a sheath connector (350) configured to attach the needle sheath to the actuator device. The needle connector is configured to disengage the needle from the actuator device when the needle experiences a force in the sliding direction that exceeds a threshold force. Additionally or alternatively, the sheath connector is configured to disengage the needle sheath from the actuator device when the needle sheath experiences a force in a direction opposite the sliding direction that exceeds a threshold force.

Description

[Technical field]

[0001] SUMMARY OF THE DISCLOSURE Embodiments herein relate to a biopsy system that includes an actuator device and a needle apparatus configured to be operatively connected to one another. [Background technology]

[0002] In the field of medicine, there are needle devices for various purposes, for example, needle devices for taking biopsy samples. In addition to the needle device, the biopsy sample taking device usually has some kind of actuator device that assists the operator in pushing the biopsy needle into the tissue and cutting the biopsy sample from the tissue. An important issue when performing a biopsy sample taking is, of course, to take measures to protect the patient against accidental damage and to minimize the risk of infection.

[0003] Prior art biopsy needles (commonly referred to as "Tru-cut" needles) have the disadvantage of collecting large amounts of tissue on the way to the target area within the patient. During insertion, the needle will often encounter areas where bacteria are present, and such bacteria are often carried to areas where the bacteria can cause infection. Such problems have typically been addressed through the use of antibiotics. However, as antibiotic resistance has increased and the efficiency of such chemical approaches to address the problem has decreased, a need exists for a different technological solution. Summary of the Invention [Problem to be solved by the invention]

[0004] In view of the above, it is an object of the present disclosure to overcome the shortcomings associated with prior art biopsy devices. [Means for solving the problem]

[0005] This object is achieved in one aspect by an actuator device for a biopsy needle device, the actuator device comprising a frame, a first actuator, a second actuator, and a third actuator, the first, second, and third actuators configured to move relative to the frame and configured to be operatively connected to the biopsy needle device.

[0006] The biopsy needle device comprises a needle sheath and a needle. The needle sheath has a proximal end and a distal end, the needle sheath forming an elongated tube with a sheath opening at the distal end of the needle sheath. The needle has proximal and distal ends and a length greater than the length of the needle sheath. The needle comprises an elongated shaft portion configured to fit within and slide relative to the needle sheath, and a tip portion connected to the shaft portion and located at the distal end of the needle. The tip portion has a lateral extent or width greater than the lateral extent or width of the sheath opening. The biopsy needle device has a closed state and an open state, the tip portion abuts the needle sheath in the closed state and the tip portion extends from the distal end of the needle sheath in the open state.

[0007] A first actuator is configured to be operably connected to the needle and configured to urge the needle a first distance d1 in a distal sliding direction relative to the needle sheath in a closed state of the needle device, where the needle device is in its open state. A second actuator is configured to be operably connected to the needle sheath and configured to urge the needle sheath a second distance d2 in a distal sliding direction relative to the needle in the open state of the needle device. A third actuator is configured to be operably connected to the needle sheath and configured to urge the needle sheath a third distance d3 in a distal sliding direction relative to the needle in the open state of the needle device, where d3 is less than d2, where the needle device is in its closed state.

[0008] Such a biopsy actuator device advantageously differs from prior art biopsy devices in that it is configured to operate in at least a three-step pushing sequence. The three-step pushing sequence is effective in performing the actual biopsy and is also safe in that it minimizes the risk of causing damage to the needle tip and thereby injuring the patient. This configuration of the actuator device allows to avoid undesired collisions between the sheath and the needle tip after the steps of pushing the needle forward into the tissue and pushing the sheath forward (thereby cutting the biopsy sample). This is because the actuator device pushes the sheath forward a relatively long distance when cutting the tissue, and the length of this second pushing step is slightly shorter than the complete distance that closes the needle device in the closed state. The remaining short distance is then covered by the sheath upon actuation by the third actuator during the third step, thereby closing the needle device.

[0009] Thus, this device is different from prior art biopsy systems with Tru-cut needles. Prior art Tru-cut needles with needles in sheaths have an open tip. Such needle movement is realized in two steps by prior art actuators, where the needle is first pushed forward and then the sheath is pushed forward to cut the sample tissue. The absence of a distal stop allows the prior art sheath to move freely relative to the needle, so there is no need for high precision in the sheath movement. Thus, when using a biopsy needle device with a closed tip as defined herein with a prior art actuator device, a stronger collision occurs between the needle tip and the sheath, which creates a significant risk of damaging the needle tip or even dislodging the needle tip from the needle. Needless to say, a damaged or dislodged needle tip inside the patient is an undesirable situation in the context of a biopsy. Moreover, in a typical procedure, multiple biopsies are performed using one identical needle (on one and the same patient). In such cases, the importance of avoiding damage to the needle is even higher. This is because any damage is usually in the form of sharp edges, lips and crevices that can collect bacteria, thereby increasing the risk of infection.

[0010] By achieving three-step needle and sheath movement as achieved by the actuator device defined in this specification, safe and accurate closure of the needle is achieved, thereby avoiding the disadvantages of prior art biopsy systems.

[0011] The first actuator may be configured to push the needle with a movement having a first maximum speed, the second actuator may be configured to push the needle sheath with a movement having a second maximum speed, and the third actuator may be configured to push the needle sheath with a movement having a third maximum speed, the third maximum speed being lower than the second maximum speed.

[0012] Such an actuator configuration has the added benefit of minimizing the risk of causing damage to the needle tip during the three step advance sequence. By minimizing the third velocity, i.e. the velocity of the sheath when setting the needle device to the closed state, any impact imparted by the sheath to the needle tip is minimized, equally minimizing the risk of damage.

[0013] An actuator may be configured to bias the needle sheath against the tip portion of the needle at all relative positions between the needle sheath and the tip portion.

[0014] By biasing the sheath and the tip of the needle towards each other, the first and / or second actuators in such a configuration prevent any gap between the sheath opening and the tip during insertion and retraction of the needle device. For example, such biasing may be achieved by configuring a spring in association with the actuator, as exemplified below. In other words, the tip and sheath may be biased towards each other at all times except during their operation, i.e. when the tip and sheath are actuated (and thereafter when the needle device is opened to remove a tissue sample). The force biasing the tip and sheath towards each other is sufficient to keep the tip of the needle towards the sheath even when the needle device is pushed or pulled, for example, through dense fascia.

[0015] In other words, the configuration described herein provides power by biasing the tip and sheath against each other at all times. This is safer than prior art solutions that use buttons, levers, hatches, and the like to lock the tip and sheath into contact with each other. In such prior art solutions, the movement of the needle device through tissue during use can change the tension between the tip and sheath, which can result in undesirable gaps between the tip and sheath even though the parts are locked relative to each other. In contrast, the configuration described herein overcomes such shortcomings by providing power, such as by a spring arrangement at the actuator. Additionally, the configuration described herein is simpler than any prior art solution that utilizes a locking mechanism.

[0016] Such a needle device and actuator device design combination allows for the minimization of bacterial transference, protecting the patient from infection while maintaining proper diagnosis. Given that one identical biopsy needle device may be used to perform multiple biopsies on the same patient, it is important to minimize any collection of bacteria on the needle device between individual biopsies.

[0017] As a result, the undesirable collection of, for example, bacteria on the needle device during insertion and retraction is minimized.

[0018] A first actuator may be configured to be releasably attached to the needle via a needle connector configured to disengage the needle from the first actuator when the needle experiences a force in the sliding direction that exceeds a threshold force Additionally or alternatively, a second actuator may be configured to be releasably attached to the needle sheath via a sheath connector configured to disengage the needle sheath from the second actuator when the needle sheath experiences a force in a direction opposite to the sliding direction that exceeds a threshold force.

[0019] Such needle and / or sheath connectors may be configured to include two connector parts, one or both of which are attached to or included with the respective needle and sheath actuators.

[0020] That is, with respect to the needle connector part, a first actuator may be configured to be attached to a first needle connector part of the needle connector, such that when the needle is disengaged from the first actuator, the first needle connector part disengages from a second needle connector part attached to the needle and the second needle connector part moves in a distal sliding direction relative to the first needle connector part. Alternatively, a needle connector may include a first needle connector part attached to the first actuator and a second needle connector part configured to be attached to the needle, such that when the needle is disengaged from the first actuator, the first needle connector part disengages from the second needle connector part and the second needle connector part moves in a distal sliding direction relative to the first needle connector part.

[0021] Similarly, with respect to the sheath connector part, the second actuator may be configured to be attached to a first sheath connector part of the sheath connector, such that when the needle sheath is disengaged from the second actuator, the first sheath connector part disengages from the second sheath connector part attached to the needle sheath and the first sheath connector part moves in a distal sliding direction relative to the second sheath connector part. Alternatively, the sheath connector may comprise a first sheath connector part attached to the second actuator and a second sheath connector part configured to be attached to the needle sheath, such that when the needle sheath is disengaged from the second actuator, the first sheath connector part disengages from the second sheath connector part and the first sheath connector part moves in a distal sliding direction relative to the second sheath connector part.

[0022] Such a configuration has the advantageous effect of further preventing damage to the needle device as a result of undesired collision between the sheath and the needle tip during the step of pushing the sheath distally, as discussed above. That is, if undesired collision between the sheath and the needle tip occurs, a distal force will be generated on the needle tip. In the event that the force exceeds a threshold force, which may be determined by the particular configuration of the connector parts as discussed in more detail below, the first and second connector parts will separate from each other and the connector parts attached to the needle and / or sheath will become decoupled from their respective actuators.

[0023] In one aspect, a biopsy needle device is provided that includes a needle sheath and a needle. The needle sheath has a proximal end and a distal end, the needle sheath forming an elongated tube with a sheath opening at the distal end of the needle sheath. The needle has a length that is greater than the length of the proximal and distal ends and the needle sheath. The needle includes an elongated shaft portion configured to fit within and slide relative to the needle sheath, and a tip portion connected to the shaft portion and located at the distal end of the needle. The tip portion has a lateral extent or width that is greater than the lateral extent or width of the sheath opening.

[0024] The biopsy needle device is configured to be operably connected to an actuator device, the actuator device comprising a first actuator and a second actuator, such as the actuator devices generally described above. The first actuator is configured to be operably connected to the needle and configured to push the needle in a distal sliding direction relative to the needle sheath. The second actuator is configured to be operably connected to the needle sheath and configured to push the needle sheath in a distal sliding direction relative to the needle.

[0025] The biopsy needle device further comprises a needle connector configured to attach the needle to the first actuator and a sheath connector configured to attach the needle sheath to the second actuator.

[0026] The needle connector is configured to disengage the needle from the first actuator when the needle experiences a force in the sliding direction that exceeds a threshold force Additionally or alternatively, the sheath connector is configured to disengage the needle sheath from the second actuator when the needle sheath experiences a force in a direction opposite to the sliding direction that exceeds a threshold force.

[0027] Such a configuration has the advantageous effect of further preventing damage to the needle device as a result of undesired collision between the sheath and the needle tip during the step of pushing the sheath distally, as discussed above.

[0028] The sheath connector may include a groove aligned along at least a first transverse direction relative to the sliding direction, such groove configured to cooperate with a pin of a third actuator of the actuator device, the pin configured to slide relative to the second actuator in a second transverse direction relative to the sliding direction, the second transverse direction being at an angle to the first transverse direction.

[0029] Such a configuration further enhances the advantage discussed above of further preventing damage to the needle device as a result of undesired collision between the sheath and the needle tip during the step of pushing the sheath distally.

[0030] The needle connector may include a first needle connector part configured to be attached to the first actuator and a second needle connector part attached to the needle, such that when the needle is disengaged from the first actuator, the first needle connector part disengages from the second needle connector part and the second needle connector part moves in a distal sliding direction relative to the first needle connector part.

[0031] Similarly, the sheath connector can include a first sheath connector part configured to be attached to the second actuator and a second sheath connector part attached to the needle sheath, such that when the needle sheath is disengaged from the second actuator, the first sheath connector part disengages from the second sheath connector part and the first sheath connector part moves in a distal sliding direction relative to the second sheath connector part.

[0032] Such a configuration further enhances the advantage of further preventing damage to the needle device as a result of undesired collision between the sheath and the needle tip during the step of pushing the sheath distally, as discussed above. That is, if undesired collision between the sheath and the needle tip occurs, a distal force will be generated on the needle tip. In the event that the force exceeds a threshold force, which may be determined by the particular configuration of the connector parts as discussed in more detail below, the first and second connector parts will separate from one another and the connector parts attached to the needle and / or sheath will be prevented from moving further distally.

[0033] In one aspect, there is provided a biopsy system comprising an actuator device and a biopsy needle apparatus as outlined above. Such a system may be considered a disposable apparatus. The effects and advantages of such a system correspond to those outlined above in relation to the various configurations of the actuator and biopsy apparatus. [Brief description of the drawings]

[0034] [Figure 1] FIG. 1 is a schematic perspective view showing a biopsy system. [Diagram 2] FIG. 1 is a schematic exploded view illustrating a biopsy system including an actuator device and a needle apparatus. [Figure 3a] 1 is a schematic diagram illustrating a three-step pushing sequence performed by a biopsy system including an actuator device and a needle apparatus. [Figure 3b]1 is a schematic diagram illustrating a three-step pushing sequence performed by a biopsy system including an actuator device and a needle apparatus. [Figure 3c] 1 is a schematic diagram illustrating a three-step pushing sequence performed by a biopsy system including an actuator device and a needle apparatus. [Figure 3d] 1 is a schematic diagram illustrating a three-step pushing sequence performed by a biopsy system including an actuator device and a needle apparatus. [Figure 4a] FIG. 4a is a schematic diagram showing a two-part click-fit connector. [Figure 4b] FIG. 4b is a schematic diagram showing a two-part click-fit connector. [Diagram 5] FIG. 1 is a schematic diagram showing a two-part click-fit connector. [Figure 6] FIG. 1 is a schematic diagram showing a two-part break-apart connector. [Figure 7] FIG. 1 is a schematic diagram showing a two-part friction fit connector. [Figure 8a] FIG. 8a is a schematic perspective view of a biopsy system. [Figure 8b] FIG. 8b is a schematic exploded view of the biopsy system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] 1 and 2 show a biopsy system 1 comprising an actuator device 30 and a biopsy needle device 20. The actuator device 30 comprises a frame 330, a first actuator 321, a second actuator 322 and a third actuator 323. The first actuator 321, the second actuator 322 and the third actuator 323 are configured to move relative to the frame 330 and are configured to be operatively connected to the biopsy needle device 20.

[0036] Biopsy needle device 20 comprises a needle sheath 22 and a needle 21. Needle sheath 22 has a proximal end 201 and a distal end 202, and needle sheath 22 constitutes an elongated tube having a sheath opening 203 at the distal end 202 of needle sheath 22. Needle 21 has proximal and distal ends 211 and 212, and a length greater than the length of needle sheath 22. Needle 21 comprises an elongated shaft portion 213 configured to fit within and slide relative to needle sheath 22, and a tip portion 23 connected to shaft portion 213. Tip portion 23 is located at the distal end 212 of needle 21, and tip portion 23 has a lateral extent or width greater than the lateral extent or width of sheath opening 203. The lateral extent or width of tip portion 23 may advantageously be equal to the outer lateral extent or width of sheath 22, thereby providing a smooth outer surface, thus minimizing the risk of bacterial collection during use, as discussed above. Additionally, although the sheath opening 203 and tip portion 23 are shown defining an abutment surface that is perpendicular to direction x that defines the extent of needle device 20, other geometries may be configured. For example, the sheath opening 203 and tip portion 23 may define an abutment surface that is at an angle that is not perpendicular to direction x, which angle is in the range of 20 degrees to 90 degrees.

[0037] For further illustrative details regarding needle device 20, see commonly owned European Patent Application 17700660. For example, the needle device may receive a surface treatment or heat coating intended to minimize the transfer of bacteria.

[0038] 3a-d, biopsy needle device 20 has a closed state and an open state, where in the closed state shown in Fig. 3a, tip portion 23 abuts needle sheath 22, where x0 defines the origin of sliding direction x in the closed state. Tip portion 23 extends from distal end 202 of needle sheath 22 in the open state shown in Fig. 3b.

[0039] A first actuator 321 is configured to be operatively connected to the needle 21 and configured to push the needle 21 a first distance d1 from an origin x0 in a distal sliding direction x relative to the needle sheath 22 in a closed state of the needle device 20, where the needle device 20 is in its open state. That is, a first pushing step of a three-step pushing sequence is illustrated by the transition from the closed state shown in Figure 3a to the open state shown in Figure 3b. During such first pushing step, the needle enters the tissue and the recess 24 at the proximal end of the needle 21 is filled with tissue to be biopsy sampled.

[0040] A second actuator 322 is configured to be operatively connected to the needle sheath 22 and configured to push the needle sheath 22 a second distance d2 in a distal sliding direction relative to the needle 21 in the open state of the needle device 20. That is, a second pushing step of the three-step pushing sequence is illustrated by transitioning from the open state shown in Figure 3b to the open state shown in Figure 3c (note that the open state is maintained as long as the tip portion 23 of the needle 21 does not abut the needle sheath 22). During such second pushing step, the needle sheath 22 will cut the tissue sample, and the tissue sample will be retained within the recess 24 in the needle 21.

[0041] Such connection of the first actuator 321 to the needle 21 and the second actuator 322 to the sheath 22 may be achieved by a needle connector 370 and a sheath connector 350, respectively, as illustrated in FIG.

[0042] For example, by configuring the needle connector 370 and the sheath connector 350 such that the attachment of the needle connector 370 and the sheath connector 350 to the first actuator 321 and the second actuator 322, respectively, is configured in terms of elastic force, it is possible to obtain a configuration of the first actuator 321 and / or the second actuator 322 for spring-biasing the needle sheath 22 against the tip portion 23 of the needle 21 in all relative positions between the needle sheath 22 and the tip portion 23.

[0043] A third actuator 323 is configured to be operatively connected to the needle sheath 22 and configured to push the needle sheath 22 a third distance d3 in the distal sliding direction x relative to the needle 21 in the open state of the needle device, where d3 is less than d2, where the needle device 20 is in its closed state. That is, the third pushing step of the three-step pushing sequence is illustrated by the transition from the open state shown in Figure 3c to the closed state shown in Figure 3d.

[0044] For a three-step pushing sequence, the first actuator 321 may be configured to push the needle 21 with a movement having a first maximum velocity v1. The second actuator 322 may be configured to push the needle sheath 22 with a movement having a second maximum velocity v2. The third actuator 323 may be configured to push the needle sheath 22 with a movement having a third maximum velocity v3, where v3 is lower than v2.

[0045] As illustrated in Figures 1 to 3, the first actuator 321 may comprise a first slider 32 and a spring 37. The first slider, in such an embodiment, is configured to slide relative to the frame 330 in a sliding direction x, and the first spring 37 is configured to bias the first slider 32 against the frame 330. Similarly, the second actuator 322 may comprise a second slider 33 and a second spring 38. In this case, the second slider 33 is configured to slide relative to the frame 330 in a sliding direction x, and the second spring 38 is configured to bias the second slider 33 against the frame 330. The third actuator 323 may comprise a pin 34 and a third spring 39. In this case, the third spring 39 is configured to bias the pin 34 against the second slider 33.

[0046] An actuator in this configuration provides the force that keeps the tip section 23 and sheath 22 biased against each other as the needle device 20 is inserted and retracted through tissue, the advantages of which are outlined above.

[0047] As illustrated, a frame 330 can include a frame base 331 and an axle 332, with the axle 332 having a longitudinal extent in the sliding direction x and disposed to pass through the frame base 331. A first actuator 321 and a second actuator 322, in such an embodiment, are disposed along the axle 332 proximal and distal to the frame base 331, respectively, with respective springs 37, 38 disposed to provide a force to push the first actuator 321 and the second actuator 322, as discussed above.

[0048] The configuration of the first and second actuators 321, 322 to urge the needle 21 and sheath 22 in a distal sliding direction x at a first distance d1 and a second distance d2 may involve the configuration of the respective sliders 32, 33 in terms of their respective sizes and positions relative to the parts 331, 332 of the frame 330. With respect to the configuration of the actuators 321, 322 in terms of urging the needle 21 and sheath 22 with movements having velocities v1 and v2, respectively, the respective springs 37, 38 may be selected in terms of length and other characteristics to provide an appropriate force.

[0049] With respect to the third actuator 323, the pin 34 may be configured to cooperate with a groove 36 in a sheath connector 350 attached to the needle sheath 22. As illustrated, the groove 36 may be aligned along at least a first transverse direction y1 relative to the sliding direction x, and the pin 34 may be configured to slide relative to the second actuator 322 in a second transverse direction y2 relative to the sliding direction x. The second transverse direction y2 is at a constant angle with respect to the first transverse direction y1. Although Figures 2 and 3a-d illustrate the groove 36 being straight along the first direction y1, it is illustrated below that the groove 36 may also be curved and thus may be defined by a series of directions, including the first transverse direction y1, that are different from the second transverse direction y2. 2 and 3a-d, the pin 34 may be attached to the pin base 341 to cooperate with a groove 342 in the second actuator 322 and a groove 344 in the first pin guider 343, so as to be guided along the second lateral direction y2 when pushed by a third spring 39 disposed within the pin base 314. The pin guider 343 may be disposed on top of the sheath connector 350 (i.e., as defined by the z direction) as illustrated in the drawings, or between the sheath connector 350 and the second actuator 322, for example.

[0050] Configuring the groove 36 in the sheath connector 350 with a first lateral direction y1 relative to the second lateral direction y2 (or with a curve defined by a series of directions including the first lateral direction y1) allows for configuring a third distance d3 and a third velocity v3 (or a varying velocity v3 in the case where the groove 36 is curved) for pushing the needle sheath 22 during the third pushing step of the three-step pushing sequence described above. It is noted that the third spring 39 may be configured in terms of length and other characteristics for pushing the pin 34 along the grooves 342, 344 at the appropriate velocity.

[0051] As shown in Fig. 3a, the first actuator 321, the second actuator 322 and the third actuator 323 are provided with potential energy by their respective springs 37, 38, 39 compressed along their respective configured directions x and y2. That is, the first actuator 312 is loaded by retraction of the first slider 32 in a direction -x opposite to the sliding direction x to a proximal position relative to the axle 332 of the frame 330. This retraction can be performed by manual interaction with the first slider 32, either directly or via any suitable auxiliary retraction device, and can be locked in the retracted position by suitable locking means. These details are outside the scope of this disclosure.

[0052] Similarly, the second actuator 332 is loaded by retraction of the second slider 33 in a direction -x opposite the sliding direction x to a position immediately adjacent and distal to the frame base 331 of the frame 330. Upon retraction, the positions of the first slider 32 and the second slider 33 relative to the frame base 331 establish an origin of x0 in the closed state, and a constant closing force is provided by the tip portion 23 on the sheath 22. As with the first actuator 321, retraction of the second slider 33 may be performed by manual interaction with the second slider 33, either directly or via any suitable auxiliary retraction device, and may be locked in the retracted position by suitable locking means. These details are outside the scope of this disclosure.

[0053] The third actuator 323 is loaded as a result of the retraction of the second slider 33 as described above and as a result of the interaction with the second pin guider 345. Starting from the unloaded state shown in Fig. 3d, the pin 34 is in a position along the direction y2 that places the pin 34 directly adjacent to the second pin guider 345. The second pin guider 345 is configured with a guide groove 346 that guides the pin 34 in the direction -y2 opposite the second lateral direction y2 to a position relative to the second pin guider 345 as shown in Fig. 3a when the second slider 33 is retracted in the direction -x.

[0054] As illustrated, the guide groove 346 extends from the distal end of the second pin guider 345 and exits from a side portion 347 in the second pin guider 345. The second pin guider 345 has elasticity in the direction z, which is achieved by being attached to a leaf spring 348 that is fixed to the housing 31 or is part of the housing 31. When the pin 34 is retracted along the -x direction in the guide groove 346, it presses the second pin guider 345 and bends it in the direction z due to its elasticity. When it exits from the side portion 347 of the second pin guider 345, the second pin guider 345 bends again in the opposite -z direction. Because the side portion opening 347 has a limited extension range in the direction z, it is possible to avoid guiding the pin 34 back into the guide groove 346 when it is pushed in the distal sliding direction x during the third pushing step of the three-step pushing sequence. This avoidance of being guided back into the guide groove 346 can be inferred from the position of the pin 34 shown in Figures 3a and 3c.

[0055] Once energized with potential energy by their respective springs 37, 38, 39 as described above, the first actuator 321, the second actuator 322, and the third actuator 323 may be actuated to release their potential energy by an actuating assembly, such as as a result of manual interaction, to perform the function of releasing the first actuator 321, thereby releasing the second actuator 322 and the third actuator 323, resulting in the three-step thrust sequence described above.

[0056] Advantageously, actuation of the third actuator 323 should not occur until the second actuator 322 has stopped moving in the sliding direction x, which can be achieved by configuring the pin 34 and the second pin guider 345 to fit closely together. Further details regarding the actuation assembly are illustrated below in connection with Figure 8a.

[0057] At start-up, needle device 20 undergoes the three-step pushing sequence described above, after which it reaches a closed state where a constant closing force is provided by tip portion 23 on sheath 22. This closing force by tip portion 23 on sheath 22 is provided in this closed state by the force of third spring 39 via pin 34 acting on sheath connector 350 via groove 36.

[0058] As outlined above, an advantage of the arrangements described herein is that various configurations of the actuator device 30 and needle apparatus 20 enable the needle apparatus 20 to be prevented from being damaged as a result of undesired collision between the needle sheath 22 and the needle tip portion 23 during the step of pushing the sheath 22 distally.

[0059] For example, the first actuator 321 may be configured to be releasably attached to the needle 21 via a needle connector 370, the needle connector 370 configured to disengage the needle 21 from the first actuator 321 when the needle 21 experiences a force in a sliding direction x that exceeds a threshold force. Additionally or alternatively, the second actuator 322 may be configured to be releasably attached to the needle sheath 22 via a sheath connector 350, the sheath connector 350 configured to disengage the needle sheath 22 from the second actuator 322 when the needle sheath 22 experiences a force in a direction -x opposite the sliding direction x that exceeds a threshold force. Such force limiting security configurations of the actuator device 30 and the needle apparatus 20 may be realized in various ways, as exemplified below with reference to Figures 4a-b and 5-7.

[0060] For example, the first actuator 321 may be configured to be attached to a first needle connector part 371 of the needle connector 370. In such a configuration, when the needle 21 is disengaged from the first actuator 321, the first needle connector part 371 disengages from a second needle connector part 372 attached to the needle 21, and the second needle connector part 372 moves in a distal sliding direction x relative to the first needle connector part 371.

[0061] Alternatively, the needle connector 370 may comprise a first needle connector part 371 attached to the first actuator 321 and a second needle connector part 372 configured to be attached to the needle 21. In such a configuration, when the needle 21 is disengaged from the first actuator 321, the first needle connector part 371 disengages from the second needle connector part 372 and the second needle connector part 372 moves in a distal sliding direction x relative to the first needle connector part 371.

[0062] Similarly, the second actuator 322 may be configured to be attached to the first sheath connector part 351 of the sheath connector 350. In such a configuration, when the needle sheath 22 is disengaged from the second actuator 322, the first sheath connector part 351 is disengaged from the second sheath connector part 352 attached to the needle sheath 22, and the first sheath connector part 351 moves in the distal sliding direction x relative to the second sheath connector part 352.

[0063] Alternatively, the sheath connector 350 can comprise a first sheath connector part 351 attached to the second actuator 322 and a second sheath connector part 352 configured to be attached to the needle sheath 22. In such a configuration, when the needle sheath 22 is disengaged from the second actuator 322, the first sheath connector part 351 disengages from the second sheath connector part 352 and the first sheath connector part 351 moves in a distal sliding direction x relative to the second sheath connector part 352.

[0064] The needle connector 370 and / or the sheath connector 350 may be in the form of a click-fit arrangement of first 371, 351 and second 372, 352 connector parts, respectively.

[0065] FIG. 4a illustrates such a click-fit sheath connector 350 comprising a first sheath connector part 351 configured to be attached to the second actuator 322 and a second connector part 352 attached to the sheath 22. The first connector part 351 is configured to move freely relative to the sheath 22. The first connector part 351 interacts with a pin 34 of the third actuator 323 via a groove 36 (exemplified here by a curved groove 36). As shown in FIG. 4b, the configuration of the threshold force at which the click-fit will be disengaged can be achieved by appropriately selecting the material of the connector 350 and the spatial dimensions of the first connector part 315 and the second connector part 352, as will be understood by those skilled in the art.

[0066] 5 illustrates such a click-fit needle connector 370 comprising a first needle connector part 371 configured to be attached to a first actuator 321 and a second connector part 372 attached to the needle 21. The configuration of the threshold force at which the click-fit will be disengaged can be achieved by appropriate selection of the materials of the connector 370 and the spatial dimensions of the first connector part 371 and the second connector part 372, as will be understood by one of ordinary skill in the art.

[0067] The needle connector 370 and / or the sheath connector 350 may be in a break-apart configuration of the respective first connector parts 371, 351 and second connector parts 372, 352.

[0068] 6 illustrates such a break-apart needle connector 370 comprising a first connector part 371 configured to be attached to a first actuator 321 and a second connector part 372 configured to be attached to a needle 21. When the needle 21 is subjected to a force in sliding direction x that exceeds a threshold force, the connector bridge 380 breaks and the second connector part 372 moves in the distal sliding direction x relative to the first connector part 371. The configuration of the threshold force that will cause the connector bridge 380 to break can be achieved by appropriate selection of the materials of the connector 370 (including the connector bridge 380) and the spatial dimensions of the connector bridge 380, as will be understood by one of ordinary skill in the art.

[0069] The needle connector 370 and / or the sheath connector 350 may be in the form of a friction fit arrangement of respective first connector parts 371, 351 and second connector parts 372, 352.

[0070] 7 illustrates such a friction fit needle connector 370 comprising a first connector part 371 configured to be attached to a first actuator 321 and a second connector part 372 configured to be attached to a needle 21. When the needle 21 is subjected to a force in sliding direction x that exceeds a threshold force, the friction force between the first connector part 371 and the second connector part 372 is overcome by the force in sliding direction x and the second connector part 372 moves in the distal sliding direction x relative to the first connector part 371. The configuration of the threshold force at which the friction force will be overcome can be achieved by selecting the material of the connector 370 and the spatial dimensions of the friction fit between the connector parts 371 and 372, as will be understood by one of ordinary skill in the art.

[0071] In the embodiment illustrated above, a third actuator 323 is configured to be operatively connected to the needle sheath 22 and configured to push the needle sheath 23 a third distance d3 in the distal sliding direction x relative to the needle 21 in the open state of the needle device 20, where d3 is smaller than d2, where the needle device 20 is in its closed state. That is, generally speaking, a three-step sequence is performed when opening and closing the needle device 20, where the third step comprises a short relative movement between the needle 21 and the sheath 22. An example of such a three-step sequence comprising three pushing steps will now be described.

[0072] However, it is envisioned that such a three-step sequence may involve both a push-forward step and a pull-back step. That is, in other embodiments, the third actuator may be configured to pull the needle back in a proximal direction a short distance and at a limited speed after pushing the needle and sheath distally. Such a configuration may be achieved by disposing the third actuator at the first actuator. In such embodiments, the needle connector may have a groove along a direction that is aligned along a direction that is + / - 180 degrees to the groove 36 exemplified above in connection with the description of the third actuator 323.

[0073] The above has focused on describing the actuator device 30 and various exemplary configurations thereof for interaction with the biopsy needle device 20. The following will focus on describing the biopsy needle device 20 and various exemplary configurations thereof for interaction with the actuator device 30. Please refer to Figures 1 to 7.

[0074] Such a biopsy needle device 20 comprises a needle sheath 22 having a proximal end 201 and a distal end 202. The needle sheath 22 defines an elongated tube having a sheath opening 203 at the distal end 202 of the needle sheath 22.

[0075] The biopsy needle device 20 further comprises a needle 21, the needle 21 having a proximal end 211 and a distal end 212, and a length greater than the length of the needle sheath 22. The needle 21 comprises an elongate shaft portion 213 configured to fit within and slide relative to the needle sheath 22, and a tip portion 23 connected to the shaft portion 213 and located at the distal end 212 of the needle 21. The tip portion 23 has a lateral extent or width greater than the lateral extent or width of the sheath opening 203. The lateral extent or width of the tip portion 23 may advantageously be equal to the outer lateral extent or width of the sheath 22, thereby minimizing the risk of bacteria collection during use as discussed above. Furthermore, the sheath opening 203 and tip portion 23 as shown define an abutment surface that is perpendicular to the direction x that defines the extent of the needle device 20, although other geometries may be configured. For example, the sheath opening 203 and the tip portion 23 can define an abutment surface that is at a non-perpendicular angle to the direction x, the angle being within the range of 20 degrees to 90 degrees.

[0076] The biopsy needle device 20 is configured to be operably connected to an actuator device 30 comprising a first actuator 321 and a second actuator 322, the first actuator 321 is configured to be operably connected to the needle 21 and configured to push the needle 21 in a distal sliding direction x relative to the needle sheath 22, and the second actuator 322 is configured to be operably connected to the needle sheath 22 and configured to push the needle sheath 22 in the distal sliding direction x relative to the needle 21.

[0077] The biopsy needle device 20 further comprises a needle connector 370 configured to attach the needle 21 to the first actuator 321 and a sheath connector 350 configured to attach the needle sheath 22 to the second actuator 322. The needle connector 370 is configured to disengage the needle 21 from the first actuator 321 when the needle 21 is subjected to a force in a sliding direction x that exceeds a threshold force. Additionally or alternatively, the sheath connector 350 is configured to disengage the needle sheath 22 from the second actuator 322 when the needle sheath 22 is subjected to a force in a direction -x opposite to the sliding direction x that exceeds a threshold force.

[0078] The sheath connector 350 may comprise at least a groove 36 aligned along a first transverse direction y1 relative to the sliding direction x, the groove 36 configured to cooperate with a pin 34 of a third actuator 323 of the actuator device 30. Such pin 34 is configured to slide relative to the second actuator 322 in a second transverse direction y2 relative to the sliding direction x, the second transverse direction y2 being at an angle to the first transverse direction y1. The groove 36 may be curved in a range of directions including the first transverse direction y1.

[0079] The needle connector 370 may comprise a first needle connector part 371 configured to be attached to the first actuator 321 and a second needle connector part 372 attached to the needle 21. In such a configuration, when the needle 21 is disengaged from the first actuator 321, the first needle connector part 371 disengages from the second needle connector part 372 and the second needle connector part 372 moves in a distal sliding direction x relative to the first needle connector part 371.

[0080] The sheath connector 350 can include a first sheath connector part 351 configured to be attached to the second actuator 322 and a second sheath connector part 352 attached to the needle sheath 22. In such a configuration, when the needle sheath 22 is disengaged from the second actuator 322, the first sheath connector part 351 disengages from the second sheath connector part 352 and the first sheath connector part 351 moves in a distal sliding direction x relative to the second sheath connector part 352.

[0081] The needle connector 370 and / or the sheath connector 350 may be in a click-fit arrangement of the respective first connector parts 371, 351 and second connector parts 372, 352. The needle connector 370 and / or the sheath connector 350 may be in a break-apart arrangement of the respective first connector parts 371, 351 and second connector parts 372, 352. The needle connector 370 and / or the sheath connector 350 may be in a friction-fit arrangement of the respective first connector parts 371, 351 and second connector parts 372, 352.

[0082] As mentioned above, the combination of the actuator device 30 and the needle apparatus 20 is one example of a biopsy system, where the system 1 may be considered as a disposable device for use with the (non-disposable) actuator device 30. However, other combinations of parts may define other systems, although not explicitly shown. For example, a biopsy system may be defined as the combination of the needle apparatus 20 integrated with at least a portion of the first slider 32 and the second slider 33 configured to be connected to the actuator device 30. Such a system may be considered as a disposable device for use with the (non-disposable) actuator device.

[0083] Finally, with reference to Figures 1 to 7, an actuator device 30 for a biopsy needle device 20 may comprise a frame 330, a first actuator 321, a second actuator 322 and a third actuator 323, the first actuator 321, the second actuator 322 and the third actuator 323 being configured to move relative to the frame 330 and configured to be operatively connected to the biopsy needle device 20: - a biopsy needle device 20 comprising a needle sheath 22 and a needle 21; - constructing a needle sheath 22 as an elongated tube having a proximal end 201 and a distal end 202, the needle sheath 22 having a sheath opening 203 at the distal end 202 of the needle sheath 22; - the needle 21 has a proximal end 211 and a distal end 212 and has a length greater than the length of the needle sheath 22, the needle 21 comprising an elongate shaft portion 213 configured to fit within and slide relative to the needle sheath 22, and a tip portion 23 connected to the shaft portion 213 and located at the distal end of the needle 21, the tip portion 23 having a lateral extent or width greater than the lateral extent or width of the sheath opening 203; - the biopsy needle device 20 has a closed state and an open state, in which the tip portion 23 abuts the needle sheath 22 in the closed state and the tip portion 23 extends from the distal end 202 of the needle sheath 22 in the open state; a first actuator 321 is configured to be operatively connected to the needle 21 and configured to push the needle 21 a first distance d1 in a distal sliding direction x relative to the needle sheath 22 in a closed state of the needle device 20, where the needle device 20 is in its open state; a second actuator 322 is configured to be operatively connected to the needle sheath 22 and configured to urge the needle sheath 22 a second distance d2 in the distal sliding direction x relative to the needle 21 in the open state of the needle device 20; a third actuator 323 is configured to be operatively connected to the needle sheath 22 and configured to push the needle sheath 22 a third distance d3 in the distal sliding direction x relative to the needle 21 in the open state of the needle device, where d3 is smaller than d2, wherein the needle device 20 is in its closed state.

[0084] for example: - the first actuator 321 is configured to push the needle 21 with a movement having a first maximum speed v1, the second actuator 322 is configured to push the needle sheath 22 with a movement having a second maximum speed v2, and the third actuator 323 is configured to push the needle sheath 22 with a movement having a third maximum speed v3, v3 being lower than v2.

[0085] for example: a first actuator 321 comprises a first slider 32 configured to slide relative to a frame 330 in a sliding direction x, and a first spring 37 configured to bias the first slider 32 relative to the frame 330; the second actuator 322 comprises a second slider 33 configured to slide relative to the frame 330 in a sliding direction x, and a second spring 38 configured to bias the second slider 33 relative to the frame 330; a third actuator 323 comprises a pin 34 and a third spring 39 , the third spring 39 being configured to bias the pin 34 against the second slider 33 .

[0086] for example: the actuators 321 , 322 , 323 are configured to bias the needle sheath 22 against the tip portion 23 of the needle 21 in all relative positions between the needle sheath 22 and the tip portion 23 .

[0087] for example: - the pin 34 is configured to cooperate with a groove 36 in a sheath connector 350 attached to the needle sheath 22, the groove 36 being aligned along at least a first transverse direction y1 relative to the sliding direction x, and the pin 34 is further configured to slide relative to the second actuator 322 in a second transverse direction y2 relative to the sliding direction x, the second transverse direction y2 being at a constant angle a with respect to the first transverse direction y1.

[0088] for example: - the first actuator 321 is configured to be releasably attached to the needle 21 via the needle connector 370, the needle connector 370 being configured to disengage the needle 21 from the first actuator 321 when the needle 21 is subjected to a force in the sliding direction x that exceeds a threshold force.

[0089] for example: a first actuator 321 configured to be attached to a first needle connector part 371 of a needle connector 370: When the needle 21 is disengaged from the first actuator 321, the first needle connector part 371 is disengaged from the second needle connector part 372 attached to the needle 21 and the second needle connector part 372 moves in the distal sliding direction x relative to the first needle connector part 371.

[0090] for example: a needle connector 370 comprising a first needle connector part 371 attached to the first actuator 321 and a second needle connector part 372 configured to be attached to the needle 21: When the needle 21 is disengaged from the first actuator 321, the first needle connector part 371 is disengaged from the second needle connector part 372 and the second needle connector part 372 moves in the distal sliding direction x relative to the first needle connector part 371.

[0091] for example: the second actuator 322 is configured to be releasably attached to the needle sheath 22 via the sheath connector 350, the sheath connector 350 being configured to disengage the needle sheath 22 from the second actuator 322 when the needle sheath 22 is subjected to a force in a direction -x opposite to the sliding direction x that exceeds a threshold force.

[0092] for example: - a second actuator 322 configured to be attached to a first sheath connector part 351 of a sheath connector 350: When the needle sheath 22 is disengaged from the second actuator 322, the first sheath connector part 351 is disengaged from the second sheath connector part 352 attached to the needle sheath 22, and the first sheath connector part 351 moves in the distal sliding direction x relative to the second sheath connector part 352.

[0093] for example: a sheath connector 350 comprising a first sheath connector part 351 attached to the second actuator 322 and a second sheath connector part 352 configured to be attached to the needle sheath 22: When the needle sheath 22 is disengaged from the second actuator 322, the first sheath connector part 351 is disengaged from the second sheath connector part 352 and the first sheath connector part 351 moves in the distal sliding direction x relative to the second sheath connector part 352.

[0094] for example: The needle connector 370 and / or the sheath connector 350 may include: - the click-fit arrangement of the respective first connector parts 371, 351 and second connector parts 372, 352; - a break-apart configuration of the respective first connector parts 371, 351 and second connector parts 372, 352; - a friction fit arrangement of the respective first connector parts 371, 351 and second connector parts 372, 352 Either:

[0095] The biopsy system 1 may comprise an actuator device 30 and a biopsy needle device 20 of any of these embodiments.

[0096] 8a and 8b, another embodiment of a biopsy system 1 is described comprising an actuator device 30 and a biopsy needle apparatus 20. The actuator device 30 comprises a frame 330, a first actuator 321, a second actuator 322 and a third actuator 323. The first actuator 321, the second actuator 322 and the third actuator 323 are configured to move relative to the frame 330 and to be operatively connected to the biopsy needle apparatus 20 in a manner similar to that described above in relation to Figures 1, 2 and 3a-d.

[0097] An actuating assembly 390 is connected at a proximal end of the body 31 of the actuator device 30. The actuating assembly 390 comprises trigger assembly parts including a releaser 391, which holds the proximal end of the first actuator 321 and initiates actuation of the series of the first actuator 321, the second actuator 322, and the third actuator 323 to release their potential energy. Further details regarding the actuating assembly are outside the scope of this disclosure.

[0098] The needle 21 is connected to the first actuator 321 via a needle connector 370. A biasing spring 369 provides a biasing force between the needle sheath 22 and the tip portion 23 of the needle 21 in an initial loaded configuration, which provides potential energy to the first actuator 321, the second actuator 322, and the third actuator 323, as discussed above. As illustrated in FIG. 8a, the biasing spring 369 provides a biasing force by a pin arrangement having a guider 361 and a biasing pin 364, which is disposed in a guide groove 362 of the first actuator 321 and connected to the needle connector 370 via a connector hole 365. Upon application of potential energy to the first actuator 321 via the spring 37, the biasing spring 369 is compressed and provides a force pulling the needle 21 proximally, thereby abutting the needle tip 23 against the distal end of the needle sheath 22, which is desired as discussed above. This arrangement of the biasing spring 369 and biasing pin 364 moving within the guide groove 362 further reduces the risk of damage to the needle tip 23 in the event of "overloading" the spring 37 acting on the first actuator 321 during application of potential energy in the initial state as discussed above.

[0099] The needle sheath 22 is connected to the second actuator 322 by the sheath connector 350, and the second actuator 322 is configured to interact with the third actuator 323 via the groove 36 as discussed above. The third actuator 321 with its pin 34, pin base 341, and third spring 39 is configured to interact with the second pin guider 345 as discussed above, where the pin 34 cooperates with the groove 342 and the groove 36 in the sheath connector 350. However, in the embodiment illustrated in Figures 8a and 8b, the pin guider 345 is arranged with its guide groove 346 below the needle device 20 and facing the needle device 20 upward in the z-direction, and is attached to the frame base 331 in the cavity 340. The second slider 33 is configured with a guide space 378 in which the pin guider 345 is received. Unlike the embodiment discussed above in which the pin guider 345 is attached to a leaf spring 348 that is fixed to or is part of the housing 31 , the pin guider 345 is provided with resiliency by a pin guider spring 349 .

Claims

1. A biopsy needle device (20) comprising: a needle sheath (22) having a proximal end (201) and a distal end (202), the needle sheath (22) constituting an elongated tube having a sheath opening (203) at the distal end (202) of the needle sheath (22); a needle (21) having a proximal end (211) and a distal end (212) and a length greater than a length of said needle sheath (22), said needle (21) comprising an elongated shaft portion (213) configured for said needle (21) to fit within said needle sheath (22) and to slide relative to said needle sheath (22), and a tip portion (23) connected to said shaft portion (213) and located at said distal end (212) of said needle (21), said tip portion (23) having a lateral extent or width greater than a lateral extent or width of said sheath opening (203); Equipped with the biopsy needle device (20) is configured to be operably connected to an actuator device (30) comprising a first actuator (321) and a second actuator (322), the first actuator (321) is configured to be operably connected to the needle (21) and configured to push the needle (21) in a distal sliding direction (x) relative to the needle sheath (22), and the second actuator (322) is configured to be operably connected to the needle sheath (22) and configured to push the needle sheath (22) in the distal sliding direction (x) relative to the needle (21); The biopsy needle device (20) a needle connector (370) configured to attach the needle (21) to the first actuator (321), and a sheath connector (350) configured to attach the needle sheath (22) to the second actuator (322); the needle connector (370) is configured to disengage the needle (21) from the first actuator (321) when the needle (21) is subjected to a force in the sliding direction (x) that exceeds a threshold force; and / or the sheath connector (350) is configured to disengage the needle sheath (22) from the second actuator (322) when the needle sheath (22) is subjected to a force in a direction (-x) opposite to the sliding direction (x) that exceeds a threshold force. A biopsy needle device (20).

2. the sheath connector (350) comprises at least a groove (36) aligned along a first transverse direction (y1) relative to the sliding direction (x); the groove (36) is configured to cooperate with a pin (34) of a third actuator (323) of the actuator device (30); the pin (34) is configured to slide relative to the second actuator (322) in a second transverse direction (y2) relative to the sliding direction (x); The second lateral direction (y2) is at a constant angle (a) with respect to the first lateral direction (y1); The biopsy needle device (20) of claim 1.

3. The biopsy needle device (20) of claim 2, wherein the groove (36) is curved in a series of directions including a first transverse direction (y1).

4. the needle connector (370) comprises a first needle connector part (371) configured to be attached to the first actuator (321) and a second needle connector part (372) attached to the needle (21); when the needle (21) is disengaged from the first actuator (321), the first needle connector part (371) is disengaged from the second needle connector part (372) and the second needle connector part (372) moves in the sliding direction (x) distally relative to the first needle connector part (371); A biopsy needle device (20) according to any one of claims 1 to 3.

5. the sheath connector (350) comprises a first sheath connector part (351) configured to be attached to the second actuator (322) and a second sheath connector part (352) attached to the needle sheath (22); when the needle sheath (22) is disengaged from the second actuator (322), the first sheath connector part (351) is disengaged from the second sheath connector part (352), and the first sheath connector part (351) moves in the sliding direction (x) distally relative to the second sheath connector part (352). A biopsy needle device (20) according to any one of claims 1 to 4.

6. The biopsy needle device (20) of claim 4 or 5, wherein the needle connector (370) and / or the sheath connector (350) are of a click-fit arrangement of respective first connector parts (371, 351) and second connector parts (372, 352).

7. The biopsy needle device (20) of claim 4 or 5, wherein the needle connector (370) and / or the sheath connector (350) are in a break-apart configuration of respective first connector parts (371, 351) and second connector parts (372, 352).

8. The biopsy needle device (20) of claim 4 or 5, wherein the needle connector (370) and / or the sheath connector (350) are of friction fit arrangement of respective first connector parts (371, 351) and second connector parts (372, 352).

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