Biopsy device

Abstract

The actuator device (30) comprises first, second and third actuators (321, 322, 323) operably connected to a biopsy needle arrangement (20) comprising a needle (21) inside a sheath (22). The needle arrangement has a closed state in which a tip portion (23) abuts the needle sheath and an open state in which the tip portion extends from a distal end of the needle sheath. The first actuator pushes the needle distally relative to the needle sheath in a sliding direction x by a first distance d1 at which the needle arrangement is in its open state. The second actuator pushes the needle sheath distally relative to the needle in the sliding direction x by a second distance d2. The third actuator pushes the needle sheath distally relative to the needle in the sliding direction x by a third distance d3, where d3 is smaller than d2, at which the needle arrangement is in its closed state.

Description

Technical Field

[0001] The embodiments described herein relate to a biopsy system including actuator devices and needle devices configured to be operatively connected to each other. Background Technology

[0002] In the medical field, needle devices exist for various purposes, such as those used for biopsy sampling. In addition to the needle device, biopsy sampling devices typically include an actuator that facilitates the operator in inserting the biopsy needle into the tissue and cutting out a tissue biopsy sample. An important consideration when performing biopsy sampling is, of course, preventing accidental harm to the patient and minimizing the risk of infection.

[0003] A drawback of existing biopsy needles (often referred to as "truth-cut needles") is that they collect a large amount of tissue during insertion into the target area of ​​the patient's body. During insertion, the needle often encounters areas where bacteria are present, and these bacteria can be transported to areas where they will cause infection. This problem is typically addressed using antibiotics. However, with increasing antibiotic resistance, this chemical approach to solving the problem is becoming less efficient, necessitating different technological solutions. Summary of the Invention

[0004] In view of the above, the purpose of this disclosure is to overcome the disadvantages associated with existing biopsy equipment.

[0005] In one respect, this objective is achieved by an actuator device for a biopsy needle apparatus. The actuator device includes a frame, a first actuator, a second actuator, and a third actuator. The first, second, and third actuators are configured to move relative to the frame and are configured to be operatively connected to the biopsy needle apparatus.

[0006] The biopsy needle device includes a needle sheath and a needle. The needle sheath has a proximal end and a distal end, and the needle sheath forms an elongated tube with a sheath opening at the distal end of the needle sheath. The needle has a proximal end and a distal end, and the length of the needle is greater than the length of the needle sheath. The needle includes an elongated shaft portion configured to engage 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 lateral extension or width of the tip portion is greater than the lateral extension or width of the sheath opening. The needle device has a closed state and an open state; in the closed state, the tip portion abuts the needle sheath, and in the open state, the tip portion extends from the distal end of the needle sheath.

[0007] A first actuator is configured to be operably connected to the needle and configured to push the needle distally relative to the needle sheath in the sliding direction a first distance d1 when the needle device is in its closed state, at which point the needle device is in its open state. A second actuator is configured to be operably connected to the needle sheath and configured to push the needle sheath distally relative to the needle in the sliding direction a second distance d2 when the needle device is in its open state. A third actuator is configured to be operably connected to the needle sheath and configured to push the needle sheath distally relative to the needle in the sliding direction a third distance d3 when the needle device is in its open state, wherein d3 is less than d2, at which point the needle device is in its closed state.

[0008] Advantageously, this biopsy actuator device differs from prior art biopsy devices at least in that it is configured to operate in a three-step push sequence. The three-step push sequence efficiently performs the actual biopsy and is safe in minimizing the risk of damage to the needle tip and thus harm to the patient. The actuator device is configured to avoid unnecessary collisions between the sheath and the needle tip after the steps of pushing the needle forward into the tissue and pushing the sheath forward (thus cutting the biopsy sample). This is because the actuator device pushes the sheath forward a considerable distance when cutting the tissue, and the length of this second push step is just shorter than the entire distance to close the needle device in the closed state. The remaining short distance is then covered by the sheath during the third step when the sheath is actuated by the third actuator, thus closing the needle device.

[0009] In other words, this device differs from existing biopsy systems with tru-cut needles. Existing tru-cut needles, including the needle within a sheath, have an open tip. Movement of this needle is facilitated by an existing actuator in two steps, where the needle is initially pushed forward and then the sheath is pushed forward to cut a tissue sample. Precise precision in sheath movement is not required because there is no distal stop; the existing sheath moves freely relative to the needle. Therefore, using a closed-tip biopsy needle device as defined herein, along with an actuator device according to the prior art, results in a strong impact between the needle tip and the sheath, leading to a significant risk of damaging the needle tip or even dislodging it from the needle. Needless to say, a damaged or dislodged needle tip within the patient is undesirable in the context of a biopsy. Furthermore, it is common practice to perform multiple biopsies (for the same patient) using the same needle. In such cases, the importance of avoiding needle damage is further emphasized, as any damage will typically take the form of edges, lips, and cracks, which will collect bacteria and thus increase the risk of infection.

[0010] The three steps achieved by the actuator device as defined and described herein facilitate needle and sheath movement, providing safe and precise needle closure and thus avoiding the drawbacks of prior art biopsy systems.

[0011] The first actuator can be configured to push the needle with a first maximum speed, the second actuator can be configured to push the needle sheath with a second maximum speed, and the third actuator can be configured to push the needle sheath with a third maximum speed, wherein the third maximum speed is less than the second maximum speed.

[0012] This actuator configuration further emphasizes the advantage of minimizing the risk of damage to the needle tip portion during the three-step push sequence. By minimizing the third speed (i.e., the speed of the sheath when the needle assembly is set to the closed position), any pulsation provided by the sheath on the needle tip portion is minimized, and the risk of damage is also minimized.

[0013] The actuator can be configured to bias the needle sheath relative to the tip of the needle for all relative positions between the needle sheath and the tip portion.

[0014] By biasing the sheath and the tip of the needle toward each other, this configuration of the first and / or second actuators prevents any gap from opening between the sheath opening and the tip during insertion and retraction of the needle assembly. This biasing can be achieved, for example, by incorporating a spring into the actuator configuration, as illustrated below. In other words, the tip and sheath can always be biased against each other except when they are in action, i.e., when they are actuated (and at a later point in time when the needle assembly is opened to remove a tissue sample). The force with which the tip and sheath are biased against each other is large enough to keep the tip of the needle toward the sheath, even when the needle assembly is pushed and pulled through, for example, tight fascia.

[0015] In other words, the configuration described herein achieves dynamic force because the tip and sheath are always biased towards each other. Locking the tip and sheath together using buttons, levers, and small windows is safer than existing solutions. In such existing solutions, the tension between the tip and sheath changes due to the movement of the needle device through the tissue during use, which can lead to undesirable gaps between the tip and sheath, even though they are actually locked together. Conversely, the configuration described herein overcomes these drawbacks by providing dynamic force, for example, by arranging a spring at the actuator. Furthermore, the configuration described herein is simpler than any existing solution utilizing a locking mechanism.

[0016] The combination of needle device and actuator design allows for minimizing bacterial translocation and protecting patients from infection while maintaining adequate diagnostic accuracy. It should be remembered that the same biopsy needle device can be used to perform multiple biopsies on the same patient; it is important to minimize any bacterial collection from the needle device between biopsies.

[0017] Therefore, unnecessary collection of bacteria, such as on the needle device, is minimized during insertion and retraction.

[0018] The first actuator can 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 is subjected to a force exceeding a threshold force in the sliding direction. Alternatively, the second actuator can 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 is subjected to a force exceeding a threshold force in the direction opposite to the sliding direction.

[0019] Such pin and / or sheath connectors can be configured such that they include two connector portions, one or both of which are attached to or included in the respective pin and sheath actuator.

[0020] In other words, regarding the pin connector portion, the first actuator can be configured to attach to the first pin connector portion of the pin connector, and when the pin is disengaged from the first actuator, the first pin connector portion disengages from the second pin connector portion attached to the pin, and the second pin connector portion moves distally relative to the first pin connector portion in a sliding direction. Alternatively, the pin connector may include a first pin connector portion attached to the first actuator and a second pin connector portion configured to attach to the pin, and when the pin is disengaged from the first actuator, the first pin connector portion disengages from the second pin connector portion, and the second pin connector portion moves distally relative to the first pin connector portion in a sliding direction.

[0021] Similarly, regarding the sheath connector portion, the second actuator can be configured to attach to the first sheath connector portion of the sheath connector, and when the needle sheath is disengaged from the second actuator, the first sheath connector portion disengages from the second sheath connector portion attached to the needle sheath, and the first sheath connector portion moves distally relative to the second sheath connector portion in the sliding direction. Alternatively, the sheath connector may include a first sheath connector portion attached to the second actuator and a second sheath connector portion configured to attach to the needle sheath, and when the needle sheath is disengaged from the second actuator, the first sheath connector portion disengages from the second sheath connector portion, and the first sheath connector portion moves distally relative to the second sheath connector portion in the sliding direction.

[0022] This configuration has the advantageous effect of further preventing damage to the needle device from unnecessary collisions between the sheath and the needle tip during the step of pushing the sheath distally, as discussed above. That is, if an unnecessary collision occurs between the sheath and the needle tip, the result is a force acting on the needle tip in the distal direction. If this force exceeds a threshold force, this threshold force can be determined by the specific configuration of the connector portions, as will be discussed in more detail below, in which the first connector portion and the second connector portion will separate from each other, and the connector portion attached to the needle and / or sheath will be disconnected from its corresponding actuator.

[0023] In one aspect, a biopsy needle device is provided, comprising a needle sheath and a needle. The needle sheath has a proximal end and a distal end, and the needle sheath forms an elongated tube with a sheath opening at the distal end of the needle sheath. The needle has a proximal end and a distal end, and the length of the needle is greater than the length of the needle sheath. The needle includes an elongated shaft portion configured to engage 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 lateral extension or width of the tip portion is greater than the lateral extension or width of the sheath opening.

[0024] The biopsy needle device is configured to be operatively connected to an actuator device including a first actuator and a second actuator, such as the actuator device outlined above. The first actuator is configured to be operatively connected to the needle and configured to push the needle distally relative to the needle sheath in a sliding direction. The second actuator is configured to be operatively connected to the needle sheath and configured to push the needle sheath distally relative to the needle in a sliding direction.

[0025] The biopsy needle device also includes a needle connector configured to attach the needle to a first actuator, and a sheath connector configured to attach the needle sheath to a second actuator.

[0026] The needle connector is configured to disengage the needle from the first actuator when the needle is subjected to a force exceeding a threshold force in the sliding direction. Alternatively, the sheath connector is configured to disengage the needle sheath from the second actuator when the needle sheath is subjected to a force exceeding a threshold force in the direction opposite to the sliding direction.

[0027] This configuration has the beneficial effect of preventing damage to the needle device from unnecessary collisions 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 at least along a first lateral direction relative to the sliding direction. This groove is configured to cooperate with a pin of a third actuator of the actuator device, the pin being configured to slide relative to a second actuator in a second lateral direction relative to the sliding direction, the second lateral direction forming an angle α with the first lateral direction.

[0029] This configuration further enhances the advantage of preventing damage to the needle device from unnecessary collisions between the sheath and the needle tip during the step of pushing the sheath distally, as discussed above.

[0030] The pin connector may include a first pin connector portion configured to be attached to a first actuator and a second pin connector portion attached to a pin, and when the pin is disengaged from the first actuator, the first pin connector portion disengages from the second pin connector portion and the second pin connector portion moves distally relative to the first pin connector portion in a sliding direction.

[0031] Similarly, the sheath connector may include a first sheath connector portion configured to be attached to a second actuator and a second sheath connector portion attached to a needle sheath, and when the needle sheath is disengaged from the second actuator, the first sheath connector portion disengages from the second sheath connector portion and the first sheath connector portion moves distally relative to the second sheath connector portion in a sliding direction.

[0032] This configuration further emphasizes the beneficial effect of preventing damage to the needle device from unnecessary collisions between the sheath and the needle tip during the distalization process, as discussed above. That is, if an unnecessary collision occurs between the sheath and the needle tip, the result is a force acting on the needle tip in the distal direction. If this force exceeds a threshold force, this threshold force can be determined by the specific configuration of the connector portions, as will be discussed in more detail below, in which the first and second connector portions will separate from each other, and the connector portion attached to the needle and / or sheath will be prevented from further movement in the distal direction.

[0033] In one aspect, a biopsy system is provided, comprising an actuator device and a biopsy needle assembly as outlined above. This system can be considered a disposable device. The effects and advantages of this system correspond to those outlined above regarding the various configurations of the actuator and biopsy needle assembly. Attached Figure Description

[0034] Figure 1 This is a schematic perspective view of a biopsy system.

[0035] Figure 2 This is an exploded schematic diagram showing a biopsy system including actuator devices and needle devices.

[0036] Figures 3a to 3d This is a schematic view illustrating a three-step push sequence performed by a biopsy system that includes actuator devices and needle devices.

[0037] Figures 4a to 4bThis is a schematic view showing a two-part mating connector;

[0038] Figure 5 This is a schematic view showing a two-part mating connector;

[0039] Figure 6 This is a schematic view showing the two disconnected connectors;

[0040] Figure 7 This is a schematic view showing a two-part friction-fit connector;

[0041] Figure 8a It is a schematic perspective view of a biopsy system, and

[0042] Figure 8b This is a schematic exploded diagram of a biopsy system. Detailed Implementation

[0043] Figure 1 and Figure 2 A biopsy system 1 including an actuator device 30 and a biopsy needle assembly 20 is shown. The actuator device 30 includes 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 assembly 20.

[0044] The biopsy needle device 20 includes a needle sheath 22 and a needle 21. The needle sheath 22 has a proximal end 201 and a distal end 202, and the needle sheath 22 forms an elongated tube with a sheath opening 203 at the distal end 202. The needle 21 has a proximal end 211 and a distal end 212, and the length of the needle 21 is greater than the length of the needle sheath 22. The needle 21 includes an elongated shaft portion 213 configured to engage within and slide relative to the needle sheath 22, and a tip portion 23 connected to the shaft portion 213. The tip portion 23 is located at the distal end 212 of the needle 21, and the lateral extension or width of the tip portion 23 is greater than the lateral extension or width of the sheath opening 203. The lateral extension or width of the tip portion 23 may advantageously be equal to the outer lateral extension or width of the sheath 22, thereby making the outer surface smooth and thus minimizing the risk of bacterial collection during use, as discussed above. Furthermore, although the sheath opening 203 and tip portion 23 shown define an adjacent plane perpendicular to the direction x of the extension of the defining needle device 20, other geometries can be configured. For example, the sheath opening 203 and tip portion 23 can define an adjacent plane at an angle to the direction x, which is not a right angle, for example, an angle in the range of 20 to 90 degrees.

[0045] For further illustration of details regarding the needle device 20, refer to European patent application 17700660 by the same applicant. For example, the needle device may be the subject of surface treatment and thermal coating for the purpose of minimizing bacterial transfer.

[0046] Still referencing Figures 3a to 3d The biopsy needle device 20 has a closed state and an open state, such as Figure 3a In the closed state shown, the tip portion 23 is adjacent to the needle sheath 22, where x0 is defined as the origin along the sliding direction x in the closed state. Figure 3b In the open state shown, the tip portion 23 extends from the distal end 202 of the needle sheath 22.

[0047] The first actuator 321 is configured to be operably connected to the needle 21 and configured to push the needle 21 distally from the origin x0 in the sliding direction x relative to the needle sheath 22 a first distance d1 when the needle device 20 is in its closed state, at which point the needle device 20 is in its open state. That is, the first pushing step of the three-step pushing sequence is achieved by... Figure 3a The closed state shown transitions to Figure 3b The open state is illustrated below. During this first pushing step, the needle will enter the tissue, and the hollow portion 24 at the distal end of the needle 21 will be filled with the tissue to be used for biopsy sampling.

[0048] The second actuator 322 is configured to be operably connected to the needle sheath 22 and configured to push the needle sheath 22 distally relative to the needle 21 in the sliding direction x by a second distance d2 when the needle device 20 is in its open state. That is, the second pushing step of the three-step pushing sequence is achieved by pushing from... Figure 3b The shown open state changes to Figure 3c The open state is illustrated (it should be remembered that the open state is maintained as long as the tip portion 23 of the needle 21 is not adjacent to the needle sheath 22). During this second push step, the needle sheath 22 will cut off a tissue sample, which will be held in the hollow portion 24 in the needle 21.

[0049] Such connections can be made between the first actuator 321 and the needle 21, and between the second actuator 322 and the sheath 22, as in Figure 2 The examples are illustrated using pin connector 370 and sheath connector 350, respectively.

[0050] By configuring the needle connector 370 and the sheath connector 350, for example by configuring them to be respectively attached to the first actuator 321 and the second actuator 322, in terms of elasticity, a configuration can be obtained in which the first actuator 321 and / or the second actuator 322 spring-bias the needle sheath 22 relative to the tip portion 23 of the needle 21 for all relative positions between the first actuator 321 and / or the second actuator 322 for all relative positions between the needle sheath 22 and the tip portion 23.

[0051] The third actuator 323 is configured to be operably connected to the needle sheath 22 and configured to push the needle sheath 22 distally relative to the needle 21 in the sliding direction x by a third distance d3, where d3 is less than d2, at which point the needle device 20 is in its closed state. That is, the third pushing step of the three-step pushing sequence is achieved by... Figure 3c The open state shown has changed to Figure 3d The closed state shown is used as an example.

[0052] Regarding the three-step actuation sequence, the first actuator 321 can be configured to actuate the needle 21 at a first maximum speed v1. The second actuator 322 can be configured to actuate the needle sheath 22 at a second maximum speed v2. The third actuator 323 can be configured to actuate the needle sheath 22 at a third maximum speed v3, where v3 is less than v2.

[0053] like Figure 1 As illustrated in Figure 3, the first actuator 321 may include a first slider 32 and a spring 37. In this example, the first slider is configured to slide relative to the frame 330 in the sliding direction x, and the first spring 37 is configured to bias the first slider 32 relative to the frame 330. Similarly, the second actuator 322 may include a second slider 33 and a second spring 38. The second slider 33 is then configured to slide relative to the frame 330 in the sliding direction x, and the second spring 38 is configured to bias the second slider 33 relative to the frame 330. The third actuator 323 may include a pin 34 and a third spring 39. The third spring 39 is then configured to bias the pin 34 relative to the second slider 33.

[0054] This configuration of the actuator provides a dynamic force that keeps the tip portion 23 and the sheath 22 abutting against each other as the needle device 20 is inserted and retracted through the tissue, the advantages of which have already been summarized above.

[0055] As illustrated, frame 330 may include frame base 331 and shaft 332, shaft 332 having a longitudinal extension in the sliding direction x and being arranged to pass through frame base 331. In such an example, first actuator 321 and second actuator 322 are arranged along shaft 332 on respective proximal and distal sides of frame base 331, and corresponding springs 37, 38 are arranged to provide force to actuate first actuator 321 and second actuator 322, as discussed above.

[0056] The configuration of the first actuator 321 and the second actuator 322 pushing the needle 21 and the sheath 22 distally in the sliding direction x by a first distance d1 and a second distance d2 can relate to the configuration of the corresponding sliders 32, 33 relative to portions 331, 332 of the frame 330 in terms of their respective size and position. Regarding the configuration of the actuators 321, 322 in pushing the needle 21 and the sheath 22 with movements having velocities v1 and v2 respectively, appropriate springs 37, 38 can be selected in terms of length and other characteristics to provide suitable force.

[0057] Regarding the third actuator 323, pin 34 can be configured to cooperate with a recess 36 in the sheath connector 350 attached to the pin sheath 22. As illustrated, recess 36 can be aligned at least along a first lateral direction y1 relative to the sliding direction x, and pin 34 can be configured to slide relative to the second actuator 322 in a second lateral direction y2 relative to the sliding direction x. The second lateral direction y2 forms an angle α with the first lateral direction y1. Although Figure 2 and Figures 3a to 3d The groove 36 is illustrated as being straight along the first direction y1, but it will be illustrated below that the groove 36 may be curved and thus defined by a continuous direction (including the first transverse direction y1) different from the second transverse direction y2. Furthermore, as... Figure 2 and Figures 3a to 3d As illustrated, pin 34 can be attached to pin base 341 to cooperate with recess 342 in the second actuator 322 and recess 344 in the first pin guide 343 to be guided along the second lateral direction y2 when actuated by a third spring 39 disposed within pin base 341. As illustrated in the figures, pin guide 343 can be disposed on top of sheath connector 350 (i.e., as defined by the z-direction), or for example, disposed between sheath connector 350 and second actuator 322.

[0058] By arranging the groove 36 in the sheath connector 350 to have a first lateral direction y1 relative to the second lateral direction y2 (or a curve defined by a continuous direction including the first lateral direction y1), a third distance d3 and a third speed v3 (or a variable speed v3 if the groove 36 is curved) can be configured to push the needle sheath 22 with this third distance and this third speed during the third pushing step of the above-described three-step pushing sequence. It should be noted that, in terms of length and other characteristics, the third spring 39 can be configured to push the pin 34 along the grooves 342, 344 at an appropriate speed.

[0059] As in Figure 3a The instructions state that the first actuator 321, the second actuator 322, and the third actuator 323 are loaded with potential energy by compression of corresponding springs 37, 38, and 39 along their respective configured directions x and y2. That is, the first actuator 321 is loaded by retracting to a position proximal to the shaft 332 of the frame 330 in a direction opposite to the sliding direction x via the first slider 32. Retraction can occur directly or via any suitable auxiliary retraction device through manual interaction with the first slider 32 and is locked in the retracted position by a suitable locking member, the details of which are beyond the scope of this disclosure.

[0060] Similarly, the second actuator 322 is loaded by the second slider 33 in a direction opposite to the sliding direction x, retracting to a position close to the distal side of the frame base 331 relative to the frame 330. After retraction, the positions of the first slider 22 and the second slider 23 relative to the frame base 331 establish the x0 origin in the closed state, and a constant closing force is provided by the tip portion 23 on the sheath 22. For the first actuator 321, the retraction of the second slider 33 can occur directly or via any suitable auxiliary retraction device through manual interaction with the second slider 33 and is locked in the retracted position by a suitable locking member, the details of which are beyond the scope of this disclosure.

[0061] The third actuator 323 is loaded due to the retraction of the second slider 33 as described above and due to interaction with the second pin guide 345. From... Figure 3d The unloaded state is shown, with pin 34 positioned along direction y2, close to the distal end relative to the second pin guide 345. The second pin guide 345 is configured with a guide groove 346 that, upon retraction in direction -x by the retraction of the second slider 33, guides pin 34 to a position relative to the second pin guide 345 in direction -y2, opposite to the second lateral direction y2. Figure 3a As shown.

[0062] As illustrated, the guide groove 346 travels from the distal end of the second pin guide 345 and exits from the side portion 347 of the second pin guide 345. The second pin guide 345 is elastic in the z-direction, the elasticity being obtained by attaching a leaf spring 348, which is fixed to the housing 31 or a portion thereof. When retracted within the guide groove 346 in the -x direction, the pin 34 causes the second pin guide 345 to flex in the z-direction due to its elasticity. When exiting the side portion 347 of the second pin guide 345, the second pin guide 345 flexes back in the opposite direction to the -z direction. Due to the fact that the side opening 347 has a limited range in the z-direction, when pushed distally in the sliding x-direction during the third push step of the three-step push sequence, the pin 34 will be able to avoid being guided back into the guide groove 346. This avoidance of being guided back into the guide groove 346 can be achieved by... Figure 3a and Figure 3c The position of pin 34 is deduced from the diagram.

[0063] After being loaded with potential energy via the corresponding springs 37, 38, and 39 as described above, the first actuator 321, the second actuator 322, and the third actuator 323 can be triggered by a triggering component to release their potential energy. This triggering component performs the following function: for example, as a result of manual interaction, it releases the first actuator 321, which in turn releases the second actuator 322 and the third actuator 323, resulting in the three-step push sequence described above.

[0064] Advantageously, the triggering of the third actuator 323 should not occur until the second actuator 322 has stopped moving in the sliding direction x. This can be achieved by configuring the pin 34 and the second pin guide 345 such that they engage tightly relative to each other. Further details regarding the triggering components will be provided below. Figure 8a Example.

[0065] Upon triggering, the needle device 20 undergoes a three-step sequence as described above, after which it reaches a closed state and is provided with a constant closing force by the tip portion 23 on the sheath 22. In this closed state, the closing force generated by the tip 23 on the sheath 22 is provided by the force of the third spring 39 acting on the sheath connector 350 via the pin 34 through the groove 36.

[0066] As summarized above, the advantage of the device described herein is that the various configurations of the actuator device 30 and the needle device 20 enable the needle device 20 to be prevented from being damaged by unnecessary collisions between the needle sheath 22 and the needle tip portion 23 during the step of pushing the sheath 22 distally.

[0067] For example, a first actuator 321 may be configured to be releasably attached to a needle 21 via a needle connector 370, which is configured to disengage the needle 21 from the first actuator 321 when the needle 21 is subjected to a force exceeding a threshold force in the sliding direction x. Alternatively, a second actuator 322 may be configured to be releasably attached to a needle sheath 22 via a sheath connector 350, which is configured to disengage the needle sheath 22 from the second actuator 322 when the needle sheath 22 is subjected to a force exceeding a threshold force in the direction opposite to the sliding direction x -x. Such force-limiting safety configurations of the actuator device 30 and the needle assembly 20 can be implemented in various ways, as will be described below and referenced. Figures 4a to 4b and Figures 5 to 7 Example.

[0068] For example, the first actuator 321 can be configured to be attached to the first pin connector portion 371 of the pin connector 370. In this configuration, when the pin 21 is disengaged from the first actuator 321, the first pin connector portion 371 disengages from the second pin connector portion 372 attached to the pin 21, and the second pin connector portion 372 moves distally relative to the first pin connector portion 371 in the sliding direction x.

[0069] Alternatively, the pin connector 370 may include a first pin connector portion 371 attached to the first actuator 321 and a second pin connector portion 372 configured to be attached to the pin 21. In this configuration, when the pin 21 is disengaged from the first actuator 321, the first pin connector portion 371 disengages from the second pin connector portion 372, and the second pin connector portion 372 moves distally relative to the first pin connector portion 371 in the sliding direction x.

[0070] Similarly, the second actuator 322 can be configured to attach to the first sheath connector portion 351 of the sheath connector 350. In this configuration, when the needle sheath 22 is disengaged from the second actuator 322, the first sheath connector portion 351 disengages from the second sheath connector portion 352 attached to the needle sheath 22, and the first sheath connector portion 351 moves distally relative to the second sheath connector portion 352 in the sliding direction x.

[0071] Alternatively, the sheath connector 350 may include a first sheath connector portion 351 attached to the second actuator 322 and a second sheath connector portion 352 configured to be attached to the needle sheath 22. In this configuration, when the needle sheath 22 is disengaged from the second actuator 322, the first sheath connector portion 351 disengages from the second sheath connector portion 352 and the first sheath connector portion 351 moves distally relative to the second sheath connector portion 352 in the sliding direction x.

[0072] The pin connector 370 and / or the sheath connector 350 may be configured in the form of mating with corresponding first connector portions 371, 351 and second connector portions 372, 352.

[0073] Figure 4a An example of this mating sheath connector 350 is illustrated, wherein a first sheath connector portion 351 is configured to attach to a second actuator 322 and a second connector portion 352 is attached to a sheath 22. The first connector portion 351 is configured to move freely relative to the sheath 22. The first connector portion 351 interacts with a pin 34 of a third actuator 323 via a groove 36 (illustrated here by a bent groove 36). Figure 4b As shown, the configuration of the threshold force that disengages the mating engagement can be achieved by appropriately selecting the material of the connector 350 and the spatial dimensions of the first connector portion 351 and the second connector portion 352, as those skilled in the art will recognize.

[0074] Figure 5 An example of such a mating pin connector 370 is illustrated, wherein a first pin connector portion 371 is configured to be attached to a first actuator 321 and a second connector portion 372 is attached to a pin 21. The configuration of the threshold force disengaging the mating engagement can be achieved by appropriately selecting the material of the connector 370 and the spatial dimensions of the first connector portion 371 and the second connector portion 372, as those skilled in the art will recognize.

[0075] The pin connector 370 and / or the sheath connector 350 may be in the form of a disconnectable configuration of the corresponding first connector portions 371, 351 and second connector portions 372, 352.

[0076] Figure 6 An example of such a disconnecting pin connector 370 is illustrated, wherein a first connector portion 371 is configured to attach to a first actuator 321 and a second connector portion 372 is configured to attach to a pin 21. When the pin 21 is subjected to a force exceeding a threshold force in the sliding direction x, the connector bridge 380 disconnects and the second connector portion 372 moves distally relative to the first connector portion 371 in the sliding direction x. The configuration of the threshold force that disconnects the connector bridge 380 can be achieved by appropriately selecting the material of the connector 370 (including the connector bridge 380) and the spatial dimensions of the connector bridge 380, as those skilled in the art will recognize.

[0077] The pin connector 370 and / or the sheath connector 350 may be in the form of a friction-fit configuration of the corresponding first connector portions 371, 351 and second connector portions 372, 352.

[0078] Figure 7An example of such a friction-fit pin connector 370 is illustrated, wherein a first connector portion 371 is configured to be attached to a first actuator 321 and a second connector portion 372 is configured to be attached to a pin 21. When the pin 21 is subjected to a force exceeding a threshold force in the sliding direction x, the frictional force between the first connector portion 371 and the second connector portion 372 is overcome by the force in the sliding direction x, and the second connector portion 372 moves distally relative to the first connector portion 371 in the sliding direction x. The configuration of the threshold force to overcome the frictional force can be achieved by selecting the material of the connector 370 and the spatial dimensions of the friction fit between the connector portions 371, 372, as those skilled in the art will recognize.

[0079] In the embodiment illustrated above, the third actuator 323 is configured to be operably connected to the needle sheath 22 and configured to push the needle sheath 23 distally relative to the needle 21 in the sliding direction x by a third distance d3, where d3 is less than d2, at which point the needle device 20 is in its closed state. That is, generally, a three-step sequence is performed to open and then close the needle device 20, wherein the third step includes a short relative movement between the needle 21 and the sheath 22. Examples of such a three-step sequence including three pushing steps have been described.

[0080] However, it is anticipated that this three-step sequence may involve both pushing and pulling steps. That is, in other examples, the third actuator may be configured to pull the needle back a small distance at a limited speed in the proximal direction after pushing the needle and sheath distally. This configuration can be achieved by arranging the third actuator at the first actuator. In such examples, the needle connector may have a groove aligned along a direction at + / -180 degrees with respect to the groove 36 illustrated in the description above in conjunction with the third actuator 323.

[0081] The preceding text has focused on describing the actuator device 30 and its various exemplary configurations for interacting with the biopsy needle device 20. The following text will focus on describing the biopsy needle device 20 and its various exemplary configurations for interacting with the actuator device 30. References Figures 1 to 7 .

[0082] This biopsy needle device 20 includes a needle sheath 22 having a proximal end 201 and a distal end 202. The needle sheath 22 is formed as an elongated tube with a sheath opening 203 at the distal end 202 of the needle sheath 22.

[0083] The biopsy needle device 20 also includes a needle 21 having a proximal end 211 and a distal end 212, and the length of the needle 21 is greater than the length of the needle sheath 22. The needle 21 includes an elongated shaft portion 213 configured to engage 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 lateral extension or width of the tip portion 23 is greater than the lateral extension or width of the sheath opening 203. The lateral extension or width of the tip portion 23 may advantageously be equal to the outer lateral extension or width of the sheath 22, thereby minimizing the risk of bacterial collection during use, as discussed above. Furthermore, although the illustrated sheath opening 203 and tip portion 23 define an adjacent plane perpendicular to the direction x defining the extension of the needle device 20, other geometries may be configured. For example, the sheath opening 203 and the tip portion 23 can define an adjacent plane at an angle to the direction x, which is not a right angle, for example, an angle in the range of 20 to 90 degrees.

[0084] The biopsy needle device 20 is configured to be operatively connected to an actuator device 30, which includes a first actuator 321 and a second actuator 322. The first actuator 321 is configured to be operatively connected to the needle 21 and configured to push the needle 21 distally relative to the needle sheath 22 in the sliding direction x, and the second actuator 322 is configured to be operatively connected to the needle sheath 22 and configured to push the needle sheath 22 distally relative to the needle 21 in the sliding direction x.

[0085] The biopsy needle device 20 also includes a needle connector 370 configured to attach a needle 21 to a first actuator 321, and a sheath connector 350 configured to attach a needle sheath 22 to a 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 exceeding a threshold force in the sliding direction x. 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 exceeding a threshold force in a direction opposite to the sliding direction x (-x).

[0086] The sheath connector 350 may include a groove 36 aligned at least along a first lateral direction y1 relative to the sliding direction x, the groove 36 being configured to cooperate with a pin 34 of a third actuator 323 of the actuator device 30. This pin 34 is configured to slide relative to a second actuator 322 in a second lateral direction y2 relative to the sliding direction x, the second lateral direction y2 forming an angle α with the first lateral direction y1. The groove 36 may be bent in a continuous direction including the first lateral direction y1.

[0087] The pin connector 370 may include a first pin connector portion 371 configured to be attached to a first actuator 321 and a second pin connector portion 372 attached to a pin 21. In this configuration, when the pin 21 is disengaged from the first actuator 321, the first pin connector portion 371 disengages from the second pin connector portion 372, and the second pin connector portion 372 moves distally relative to the first pin connector portion 371 in the sliding direction x.

[0088] The sheath connector 350 may include a first sheath connector portion 351 configured to be attached to the second actuator 322 and a second sheath connector portion 352 attached to the needle sheath 22. In this configuration, when the needle sheath 22 is disengaged from the second actuator 322, the first sheath connector portion 351 disengages from the second sheath connector portion 352 and the first sheath connector portion 351 moves distally relative to the second sheath connector portion 352 in the sliding direction x.

[0089] The pin connector 370 and / or the sheath connector 350 can be configured for mating with the corresponding first connector portions 371, 351 and second connector portions 372, 352. The pin connector 370 and / or the sheath connector 350 can also be configured for disengagement with the corresponding first connector portions 371, 351 and second connector portions 372, 352. The pin connector 370 and / or the sheath connector 350 can also be configured for friction mating with the corresponding first connector portions 371, 351 and second connector portions 372, 352.

[0090] As described above, the combination of actuator device 30 and needle device 20 is an example of biopsy system 1, where system 1 can be considered a disposable device for use with (non-disposable) actuator device 30. However, although not explicitly shown, other combinations of the parts can define other systems. For example, a biopsy system can be defined as a combination of needle device 20 together with at least a portion of a first slider 32 and a second slider 33 configured to be connected to actuator device 30. Such a system can be considered a disposable device for use with (non-disposable) actuator device.

[0091] Finally, refer to Figures 1 to 7 The biopsy needle device 20 may include:

[0092] - Needle sheath 22, which has a proximal end 201 and a distal end 202, and the needle sheath 22 is formed as an elongated tube with a sheath opening 203 at the distal end 202.

[0093] - Needle 21, having a proximal end 211 and a distal end 212, and a length greater than the length of needle sheath 22, needle 21 including an elongated shaft portion 213 configured to engage 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 needle 21, the lateral extension or width of the tip portion 23 being greater than the lateral extension or width of the sheath opening 203.

[0094] in:

[0095] - The biopsy needle device 20 is configured to be operatively connected to an actuator device 30, which includes a first actuator 321 and a second actuator 322. The first actuator 321 is configured to be operatively connected to the needle 21 and configured to push the needle 21 distally relative to the needle sheath 22 in the sliding direction x, and the second actuator 322 is configured to be operatively connected to the needle sheath 22 and configured to push the needle sheath 22 distally relative to the needle 21 in the sliding direction x.

[0096] The biopsy needle device 20 also includes:

[0097] - A needle connector 370 configured to attach needle 21 to a first actuator 321 and a sheath connector 350 configured to attach needle sheath 22 to a second actuator 322.

[0098] in:

[0099] - The pin connector 370 is configured to disengage the pin 21 from the first actuator 321 when the pin 21 is subjected to a force exceeding a threshold force in the sliding direction x, and / or

[0100] -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 exceeding a threshold force in the direction -x opposite to the sliding direction x.

[0101] For example:

[0102] - The sheath connector 350 includes a groove 36 aligned at least along a first lateral 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 a second actuator 322 in a second lateral direction y2 relative to the sliding direction x. The second lateral direction y2 is at an angle α to the first lateral direction y1.

[0103] For example:

[0104] - The groove 36 is curved in a continuous direction including the first transverse direction y1.

[0105] For example:

[0106] - The pin connector 370 includes a first pin connector portion 371 configured to be attached to the first actuator 321 and a second pin connector portion 372 configured to be attached to the pin 21, and

[0107] - When the needle 21 disengages from the first actuator 321, the first needle connector portion 371 disengages from the second needle connector portion 372 and the second needle connector portion 372 moves distally relative to the first needle connector portion 371 in the sliding direction x.

[0108] For example:

[0109] - The sheath connector 350 includes a first sheath connector portion 351 configured to attach to the second actuator 322 and a second sheath connector portion 352 configured to attach to the pin sheath 22, and

[0110] - When the needle sheath 22 disengages from the second actuator 322, the first sheath connector portion 351 disengages from the second sheath connector portion 352 and the first sheath connector portion 351 moves distally relative to the second sheath connector portion 352 in the sliding direction x.

[0111] For example:

[0112] - The pin connector 370 and / or the sheath connector 350 are mating configurations of the corresponding first connector portions 371, 351 and second connector portions 372, 352.

[0113] For example:

[0114] - The pin connector 370 and / or the sheath connector 350 are disconnectable configurations of the corresponding first connector portions 371, 351 and second connector portions 372, 352.

[0115] For example:

[0116] - The pin connector 370 and / or the sheath connector 350 are friction-fit configurations of the corresponding first connector portions 371, 351 and second connector portions 372, 352.

[0117] Now go to Figure 8a and Figure 8b Further embodiments of the biopsy system 1, including actuator device 30 and biopsy needle device 20, will be described. Actuator device 30 includes frame 330, first actuator 321, second actuator 322, and third actuator 323. (In conjunction with the above) Figure 1 , Figure 2 and Figures 3a to 3dIn a similar manner as described, 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.

[0118] A trigger assembly 390 is connected to the proximal end of the body 31 of the actuator device 30. The trigger assembly 390 includes a trigger assembly portion comprising a release 391 by which the proximal end of the first actuator 321 is held, thereby initiating a sequence of triggering the first actuator 321, the second actuator 322, and the third actuator 323 to release their potential energy. Further details regarding the trigger assembly are outside the scope of this disclosure.

[0119] Needle 21 is connected to the first actuator 321 via needle connector 370. In the initial loaded configuration, bias spring 369 provides a biasing force between needle sheath 22 and the tip portion 23 of needle 21, wherein the first actuator 321, second actuator 322, and third actuator 323 have been loaded with potential energy, as discussed above. Figure 8a As illustrated, the bias spring 369 provides biasing force by means of a pin arrangement having a guide 361 and a bias pin 364, the bias pin 364 being arranged in a guide groove 362 of the first actuator 321 and connected to the needle connector 370 via a connector hole 365. When latent energy is applied to the first actuator 321 via the spring 37, the bias spring 369 is compressed and provides a force pulling the needle 21 in the proximal direction, thereby causing the needle tip 23 to abut the distal end of the needle sheath 22, as desired, as discussed above. This arrangement of the bias spring 369 and the bias pin 364 moving in the guide groove 362 also reduces the risk of damage to the needle tip 23 in the event that the spring 37 acting on the first actuator 321 is “overloaded” during the initial application of latent energy, as discussed above.

[0120] The needle sheath 22 is connected to the second actuator 322 via a sheath connector 350, which is configured to interact with the third actuator 323 via a recess 36, as discussed above. The third actuator 321, along with its pin 34, pin base 341, and third spring 39, is configured to interact with the second pin guide 345, as discussed above, wherein the pin 34 cooperates with the recess 342 and the recess 36 in the sheath connector 350. However, in Figure 8a and Figure 8bIn the illustrated embodiment, the pin guide 345 is arranged with its guide groove 346 facing upwards and in the z-direction, below which is the pin device 20, and attached to the frame base 331 in the hollow portion 340. The second slider 33 is configured with a guide space 378 in which the pin guide 345 is housed. Compared to the embodiments discussed above in which the pin guide 345 is attached to a leaf spring 348 fixed to or part of the housing 31, the pin guide 345 is elastic by means of a pin guide spring 349.

Claims

1. An actuator device (30) for a biopsy needle apparatus (20), the actuator device (30) comprising 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 being configured to be operatively connected to the biopsy needle apparatus (20), wherein: - The biopsy needle device (20) includes a needle sheath (22) and a needle (21). - The needle sheath (22) has a proximal end (201) and a distal end (202), the needle sheath (22) being an elongated tube 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 the length of the needle (21) is greater than the length of the needle sheath (22). The needle (21) includes an elongated shaft portion (213) configured to engage inside the needle sheath (22) and slide relative to the needle sheath, and a tip portion (23) connected to the shaft portion (213) and located at the distal end (212) of the needle (21). The lateral extension or width of the tip portion (23) is greater than the lateral extension or width of the sheath opening (203). - The biopsy needle device (20) has a closed state and an open state, wherein in the closed state, the tip portion (23) is adjacent to the needle sheath (22), and in the open state, the tip portion (23) extends from the distal end (202) of the needle sheath (22). - The first actuator (321) is configured to be operably connected to the needle (21) and configured to push the needle (21) distally relative to the needle sheath (22) in the sliding direction (x) by a first distance d1 when the needle device (20) is in its closed state, at which point the needle device (20) is in its open state. - The second actuator (322) is configured to be operably connected to the needle sheath (22) and configured to push the needle sheath (22) distally relative to the needle (21) in the sliding direction (x) by a second distance d2 when the needle device (20) is in its open state. - The third actuator (323) is configured to be operably connected to the needle sheath (22) and configured to push the needle sheath (22) distally relative to the needle (21) in the sliding direction (x) by a third distance d3, where d3 is less than d2, at which point the needle device (20) is in its closed state. - The first actuator (321) includes a first slider (32) configured to slide relative to the frame (330) in the sliding direction (x) and a first spring (37) configured to bias the first slider (32) relative to the frame (330). - The second actuator (322) includes a second slider (33) configured to slide relative to the frame (330) in the sliding direction (x) and a second spring (38) configured to bias the second slider (33) relative to the frame (330), and - The third actuator (323) includes a pin (34) and a third spring (39), the third spring (39) being configured to bias the pin (34) relative to the second slider (33). 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 at least along a first lateral direction (y1) relative to the sliding direction (x), and wherein the pin (34) is also configured to slide relative to the second actuator (322) in a second lateral direction (y2) relative to the sliding direction (x), the second lateral direction (y2) being at an angle (a) to the first lateral direction (y1).

2. The actuator device (30) according to claim 1, wherein: - The first actuator (321) is configured to push the needle (21) with a motion having a first maximum speed v1, the second actuator (322) is configured to push the needle sheath (22) with a motion having a second maximum speed v2, and the third actuator (323) is configured to push the needle sheath (22) with a motion having a third maximum speed v3, wherein v3 is less than v2.

3. The actuator device (30) according to claim 1, wherein: - The actuators (321, 322, 323) are configured to bias the needle sheath (22) relative to the tip portion (23) of the needle (21) for all relative positions between the needle sheath (22) and the tip portion (23).

4. The actuator device (30) according to any one of claims 1 to 3, wherein: - The first actuator (321) is configured to be releasably attached to the needle (21) via a needle connector (370) configured to disengage the needle (21) from the first actuator (321) when the needle (21) is subjected to a force exceeding a threshold force in the sliding direction (x).

5. The actuator device (30) according to claim 4, wherein: - The first actuator (321) is configured to attach to the first pin connector portion (371) of the pin connector (370), and wherein: - When the needle (21) disengages from the first actuator (321), the first needle connector portion (371) disengages from the second needle connector portion (372) attached to the needle (21) and the second needle connector portion (372) moves distally relative to the first needle connector portion (371) in the sliding direction (x).

6. The actuator device (30) according to claim 4, wherein: - The pin connector (370) includes a first pin connector portion (371) attached to the first actuator (321) and a second pin connector portion (372) configured to be attached to the pin (21), wherein: - When the needle (21) disengages from the first actuator (321), the first needle connector portion (371) disengages from the second needle connector portion (372) and the second needle connector portion (372) moves distally relative to the first needle connector portion (371) in the sliding direction (x).

7. The actuator device (30) according to any one of claims 1 to 6, wherein: - The second actuator (322) is configured to be releasably attached to the needle sheath (22) via a 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 exceeding a threshold force in a direction (-x) opposite to the sliding direction (x).

8. The actuator device (30) according to claim 7, wherein: - The second actuator (322) is configured to attach to the first sheath connector portion (351) of the sheath connector (350), and wherein: - When the needle sheath (22) is disengaged from the second actuator (322), the first sheath connector portion (351) disengages from the second sheath connector portion (352) attached to the needle sheath (22) and the first sheath connector portion (351) moves distally relative to the second sheath connector portion (352) in the sliding direction (x).

9. The actuator device (30) according to claim 7, wherein: - The sheath connector (350) includes a first sheath connector portion (351) attached to the second actuator (322) and a second sheath connector portion (352) configured to be attached to the pin sheath (22), wherein: - When the needle sheath (22) disengages from the second actuator (322), the first sheath connector portion (351) disengages from the second sheath connector portion (352) and the first sheath connector portion (351) moves distally relative to the second sheath connector portion (352) in the sliding direction (x).

10. The actuator device (30) according to any one of claims 5 to 6, 8 to 9, wherein the pin connector (370) and / or the sheath connector (350) is any one of the following: - The mating configuration of the corresponding first connector portions (371, 351) and second connector portions (372, 352), - The disconnection and separation configuration of the corresponding first connector portion (371, 351) and second connector portion (372, 352), - The friction fit configuration of the corresponding first connector portion (371, 351) and second connector portion (372, 352).

11. A biopsy system (1) comprising an actuator device (30) and a biopsy needle device (20) according to any one of claims 1 to 10.

Images