Biopsy needle device

Abstract

The present invention relates to a biopsy needle device having at least one hollow outer needle (3), an inner needle (4) guided so as to be longitudinally movable within the outer needle (3), and a housing (1, 2). Such a biopsy needle device can be used to perform a biopsy on a living organism and offers improved ergonomics.

Description

[Technical Field]

[0001] The present invention relates to a biopsy needle device having at least one hollow outer needle, an inner needle guided longitudinally movably within the outer needle, and a housing, such a biopsy needle device can be used to perform a biopsy on a living organism. [Background technology]

[0002] Such a biopsy needle device is known, for example, from DE 198 48 513 A1. Summary of the Invention

[0003] The present invention is based on the object of providing a further improved biopsy needle device.

[0004] In one embodiment of the present invention, the biopsy needle device has at least one manually actuable trigger element for triggering relative movement between the outer needle and the inner needle. Such a trigger element allows the biopsy needle device to be operated by a user. Here, the biopsy needle device can be configured as a purely manual biopsy needle device or a semi-automatic biopsy needle device. In a purely manual embodiment, the user must manually perform the full relative movement between the outer needle and the inner needle using the manually actuable trigger element, as required to perform a biopsy. In a semi-automatic embodiment, the user only needs to trigger a movement mechanism pretensioned by the trigger element and perform only a relatively small movement themselves. Any further relative movement required between the outer needle and the inner needle to perform the biopsy is then automatically performed by the movement mechanism, for example, by a pretensioned trigger spring.

[0005] The trigger element may therefore serve in particular to trigger a semi-automatic relative movement between the outer needle and the inner needle.

[0006] In one embodiment of the present invention, the biopsy needle device has at least one finger grip element for holding and / or operating the biopsy needle device with at least one finger of a user. By this means, manual operation of the biopsy needle device is configured to be easier and more comfortable, resulting in improved ergonomics. The finger grip element can be configured, in particular, as a finger grip element that can accommodate only one finger of a user or that can be operated by only one finger of a user. For example, the finger grip element can be annular with an inner recess that can accommodate a user's finger but is not suitable for accommodating several fingers.

[0007] In this regard, it should be mentioned that the biopsy needle device can also be gripped or held by the user on its housing. However, the housing itself is not considered a finger grip element within the meaning of this application. The housing can have, for example, laterally, notches or recesses that serve as finger grip elements.

[0008] Advantageously, the inner needle is connected to a trigger element in a longitudinally immovable manner, which may be, for example, part of a displacement element of a biopsy needle device. The outer needle may be fixed to the outer needle holder in a longitudinally immovable manner.

[0009] In one embodiment of the present invention, the biopsy needle device has only one finger grip element. Here, in addition to the trigger element, one finger grip element can be present, for example, spaced apart from the trigger element. In this way, the biopsy needle device can be configured very compact and small, and therefore requires very little space for use. Here, the one finger grip element can serve, for example, to receive the user's middle finger. In this case, the trigger element can be actuated, for example, by the index finger. Alternatively, the trigger element can be actuated by the user's thumb, which allows the biopsy needle device to be held particularly precisely.

[0010] In one embodiment of the present invention, the biopsy needle device has one or more finger grip elements arranged asymmetrically with respect to the longitudinal axis of the outer needle. This can improve the maneuverability and ergonomics of the biopsy needle device. Furthermore, this can result in a particularly compact design of the biopsy needle device. Again, a trigger element can be present in addition to the finger grip element, or the trigger element can be formed by one or more finger grip elements.

[0011] In one embodiment of the present invention, the biopsy needle device has at least one finger grip element at the proximal end of the housing. The proximal end of the housing is the end facing the user and, therefore, the end facing away from the patient when the biopsy needle device is used on the patient to perform a biopsy. The distal end of the housing is the end facing the patient. Using such finger grip elements, a completely new operating technique for the biopsy needle device can be realized for the user, such as a two-finger or three-finger operating technique, allowing both the initial initialization operation to set the position between the inner and outer needles before performing a biopsy and the trigger operation to perform a biopsy without changing the grip position of the user's fingers on the biopsy needle device. In this way, the biopsy needle device can be operated completely with one hand.

[0012] In one embodiment of the present invention, the biopsy needle device has exactly three finger grip elements, which further enhances the operability of the biopsy needle device, particularly supporting one-handed operability using a three-finger technique both during initial initialization and during triggering to perform a biopsy.

[0013] In the case of a semi-automatic biopsy needle device, the initialization movement serves to pretension the movement mechanism or its trigger spring.

[0014] In one embodiment of the present invention, the biopsy needle device has at least one pretensioning element that can be used to move the outer needle and inner needle relative to each other in a tension direction against the force of the trigger spring of the biopsy needle device. The trigger spring can be a tension spring or a compression spring, depending on the design of the movement mechanism. The trigger spring can be configured as, for example, a spiral spring, a torsion spring, or other elastic element, such as a block made of elastic material. The trigger spring can be a single spring or a configuration consisting of multiple springs.

[0015] In one embodiment of the present invention, the biopsy needle device is configured such that at least one finger grip element or an arrangement of at least two finger grip elements is displaceably mounted relative to the housing of the biopsy needle device in the direction of the longitudinal axis of the outer needle. In this manner, the displaceable finger grip element or the displaceable arrangement of at least two finger grip elements can be used, for example, as a trigger element and / or a pretensioning operating element for improved operation of the biopsy needle device.

[0016] The displaceably mounted finger grip element or the displaceably mounted arrangement of at least two finger grip elements can be configured so that the biopsy needle device does not increase in length when the trigger spring is pretensioned. This is possible as a result of the fact that the displaceably mounted finger grip element or the displaceably mounted arrangement of at least two finger grip elements can only be displaced within the housing. As a result, operational advantages for the user can also be realized.

[0017] In one embodiment of the present invention, the manually actuable trigger element can be actuated in an actuation direction arranged transversely to the longitudinal axis of the outer needle. In this way, triggering can be performed transversely, so to speak. This also enables different types of operation of the biopsy needle device. In addition, it is easier to perform remote triggering of the trigger element by an external actuator, for example, to avoid the user, i.e., the physician, having to perform the triggering within the range of the X-ray radiation. Remote triggering of the trigger element means that the user does not need to hold their hand within the range of the X-ray radiation.

[0018] The biopsy needle device embodiments described above and below can be combined with each other as desired.

[0019] In the embodiments described above having a transverse actuation option, i.e., an actuation direction disposed transversely relative to the longitudinal axis of the outer needle, the biopsy needle device may be optionally configured with or without a finger grip element or multiple finger grip elements. In particular, in embodiments specifically configured for remote triggering by an external actuator, the finger grip element may be omitted entirely.

[0020] According to one embodiment of the present invention, the biopsy needle device includes a guide, e.g., within the housing of the biopsy needle device, within which the trigger element is guided. The guide defines a direction of movement of the trigger element during triggering transverse to the longitudinal axis of the outer needle. For example, a perpendicular angle between the direction of movement of the trigger element and the longitudinal axis of the outer needle may be defined by the guide.

[0021] In the aforementioned embodiments of the biopsy needle device, the biopsy needle device can have at least one manually actuable trigger element that triggers relative movement between the outer needle and the inner needle. In this case, at least one finger grip element or an arrangement of at least two finger grip elements can advantageously be configured as such a trigger element. For example, the aforementioned displaceably mounted finger grip element or a displaceably mounted arrangement of at least two finger grip elements can form such a trigger element. This also has an advantageous effect on one-handed use of the biopsy needle device. Furthermore, the biopsy needle device can be configured without a separate trigger element, resulting in a simplified design.

[0022] In the case of a semi-automatic biopsy needle device, the trigger element can simultaneously function as a pretensioning element, i.e., a manual actuation element for pretensioning the semi-automatic movement mechanism. In this way, the biopsy needle device can be operated with one hand. The trigger element serves to trigger relative movement between the outer needle and the inner needle, which is caused by the force of the pretensioned trigger spring and is opposite to the tension direction.

[0023] The inner needle may be configured as a solid needle without a lumen. Advantageously, the inner needle may have a recess just before its distal end that functions as a tissue-receiving pocket.

[0024] According to one embodiment of the present invention, the biopsy needle device has, in addition to the pretensioning element, a trigger element for triggering relative movement between the outer needle and the inner needle, where the relative movement is caused by the force of the pretensioned trigger spring and is opposite to the tensioning direction. The pretensioning element allows the semi-automatic biopsy needle device to be placed in a pretensioned state, which can then be triggered by a separate, manually actuable trigger element to automatically perform the further required relative movement between the outer needle and the inner needle to perform the biopsy procedure. Here, the trigger element can be located particularly far from the pretensioning element to prevent unintentional actuation. The biopsy needle device can also have multiple trigger elements. The trigger elements can then be located at different points on the biopsy needle device and, for example, can be actuated in different actuation directions.

[0025] According to one embodiment of the present invention, the biopsy needle device has a retention mechanism that is used to retain the pretensioning element or a component connected thereto in at least one retention position, particularly at least two different retention positions, against the force of the pretensioned trigger spring when the trigger spring is pretensioned. This measure further simplifies one-handed operation of the biopsy needle device and is more advantageous for the user, since the user does not need to apply force to retain the pretensioned trigger spring. The retention mechanism can, for example, be configured as a latch mechanism.

[0026] According to one embodiment of the present invention, one, several, or all of the finger grip elements have a ring shape, which can be configured as a completely closed ring or a ring that is open at one point in the circumferential direction. This ensures that each finger grip element can accommodate one finger. The ring shape can be circular, oval, or any other ergonomically suitable ring shape. If the biopsy needle device has multiple finger grip elements, they can have the same or different configurations. Furthermore, the finger grip elements can be configured as notches or recesses on the housing.

[0027] According to one embodiment of the present invention, it is provided that one, several, or all of the finger grip elements are configured as separate components rigidly or movably coupled to the housing. This simplifies the manufacture of the biopsy needle device. In particular, a relatively simple injection mold can be used to manufacture the components.

[0028] According to one embodiment of the present invention, it is provided that the single finger grip element of the biopsy needle device is arranged on the housing offset laterally with respect to the longitudinal axis of the outer needle. This allows for a particularly ergonomically advantageous use of the biopsy needle device with only a single finger grip element. The finger grip element can be arranged on the housing offset with respect to the longitudinal axis of the outer needle, in particular, to the extent that the longitudinal axis does not obscure the single finger grip element.

[0029] According to one embodiment of the present invention, it is provided that the distance between the finger grip element located at the proximal end of the housing and the distal end of the housing is invariable. This allows for a particularly ergonomic design of the biopsy needle device for one-handed operation. In this way, at least a region of the housing of the biopsy needle device has a constant length that can be calculated in advance by the user and that does not change during operation of the biopsy needle device. This is advantageous when the movement space of the biopsy needle device is limited, for example, in a CT tube. The finger grip element located at the proximal end of the housing can be fixedly connected to the housing. For example, the finger grip element located at the proximal end of the housing can protrude from the housing in a direction away from the distal end of the housing (closer to the patient).

[0030] According to one embodiment of the present invention, the distance between the finger grip element located at the proximal end of the housing and the other finger grip elements of the biopsy needle device is at least 2 cm or at least 50% of the length of the housing of the biopsy needle device in all operating states of the biopsy needle device. The distance can also be at least 3 cm. Thus, the finger grip element located at the proximal end of the housing is positioned in a particularly comfortable ergonomic way compared to the length of the housing, where the length of the housing is considered to be the distance between the distal and proximal ends of the housing. This measure avoids excessively small distances between the finger grip elements, which also favors ergonomic one-handed operation of the biopsy needle device.

[0031] According to one embodiment of the present invention, it is provided that a docking holder is arranged on the housing of the biopsy needle device for holding an external actuator, which allows the trigger element to be remotely activated by a user. The external actuator means that the user of the biopsy needle device can be protected from having to hold their hand within the range of X-ray radiation in order to activate the trigger element, for example in the case of an X-ray examination. Thus, remote triggering of the trigger element is possible.

[0032] The docking holder may in particular enable form-fit coupling (in the sense of "docking") of an external actuator to the housing of the biopsy needle device.

[0033] The invention also relates to a set consisting of: - a biopsy needle device having at least one hollow outer needle, an inner needle guided in a longitudinally movable manner within the outer needle, and a housing, the biopsy needle device having at least one manually actuable trigger element for triggering relative movement between the outer needle and the inner needle; and - An external actuator that allows the trigger element of the biopsy needle device to be remotely triggered by the user.

[0034] As a result, the advantages described above are also achieved, in particular the aforementioned advantageous remote triggering of the biopsy needle device can be performed, thus protecting the user from unnecessary radiation exposure during x-rays or other investigations.

[0035] According to one advantageous embodiment of the present invention, the external actuator has at least one fixation element, by which the external actuator can be fixed to the biopsy needle device in a form-fitting and / or press-fit manner. For example, the fixation element can be configured to correspond to the docking holder described above. However, the biopsy needle device can also be formed without a docking holder. For example, the fixation element of the external actuator can be configured to engage around or on a specific region of the housing of the biopsy needle device. In this way, a user can couple the external actuator to the biopsy needle device with little effort.

[0036] According to one advantageous embodiment of the present invention, the external actuator has an actuation plunger for remote actuation of the trigger element of the biopsy needle device. The actuation plunger is longitudinally movable in a direction extending transversely to the longitudinal axis of the outer needle. For example, the actuation plunger can be longitudinally movable in a direction extending substantially perpendicular to the longitudinal axis of the outer needle. In this way, the biopsy needle device can be triggered from the side by the external actuator or its actuation plunger. This allows for space-saving and ergonomic handling of the biopsy needle device with a fixed external actuator, even in limited space conditions, such as within a CT tube.

[0037] It is conceivable to arrange a pistol grip in the end region of the external actuator, which has the advantage that the pistol grip constitutes an ergonomically adapted handle for the user, thus minimizing the force to be applied and at the same time improving the engagement accuracy, and further improving the grip and stability when guiding and directing the biopsy needle device.

[0038] The invention is explained in more detail below with the aid of the drawings and with reference to exemplary embodiments. In the drawing [Brief explanation of the drawings]

[0039] [Figure 1] FIG. 2 is an exploded view of the components of the biopsy needle device in the first embodiment. [Figure 2] 2 is a side view of the biopsy needle device according to FIG. 1; [Figure 3] FIG. 3 shows a detail of the biopsy needle device according to FIG. 2. [Figure 4] FIG. [Figure 5] FIG. [Figure 6] FIG. [Figure 7] FIG. 7 is a front view of the housing part according to FIG. 6; [Figure 8]7 is a side view of the housing part according to FIG. 6 from the opposite side. [Figure 9] 9 is a cross-sectional view of the housing part according to FIG. 8 at the section plane AA shown therein. [Figure 10] FIG. 10 is a side view of another housing portion having a finger grip element shown in perspective. [Figure 11] FIG. 10 is an exploded view of a second embodiment of a biopsy needle device. [Figure 12] FIG. 10 is an exploded view of a third embodiment of a biopsy needle device. [Figure 13] FIG. 13 is a top view of the biopsy needle device according to FIG. 12. [Figure 14] FIG. 13 is a side view of the biopsy needle device according to FIG. 12. [Figure 15] 13 is a perspective view of a housing part of the biopsy needle device according to FIG. 12 and its displacement element. FIG. [Figure 16] 13 is a perspective view of an outer needle holder of the biopsy needle device according to FIG. 12. FIG. [Figure 17] FIG. 10 is an exploded view of a fourth embodiment of a biopsy needle device. [Figure 18] FIG. 10 is an exploded view of an embodiment of an external actuator. [Figure 19] FIG. 10 is an exploded view of a fifth embodiment of a biopsy needle device. [Figure 20] 20 is a side cross-sectional view of the biopsy needle device according to FIG. 19. DETAILED DESCRIPTION OF THE INVENTION

[0040] FIG. 1 shows a biopsy needle device having a housing 1, 2 with two housing parts. The housing parts 1, 2 can be configured, for example, in the form of half shells. The biopsy needle device has a single finger grip element 8, which can be formed as separate components and fixed to the housing parts 1, 2. The finger grip element 8 can also be configured as a common component with the housing. The biopsy needle device further has a hollow outer needle 3 and an inner needle 4 that is guided longitudinally within the outer needle 3. A penetration depth mark 30 is arranged on the outside of the outer needle 3, and can be used to read the insertion depth of the outer needle 3 during biopsy. The inner needle 4 has a tissue window 40 for receiving a tissue sample during biopsy.

[0041] As further components of the semi-automatic movement mechanism, the biopsy needle device includes an outer needle holder 6, a displacement element 5, and a trigger spring 7. In the assembled state, the outer needle holder 6 is located in the elongated internal space 51 of the displacement element 5. The displacement element 5 is located within the housings 1, 2 in the area where the outer needle holder 6 is located within the internal space 51. The displacement element 5 protrudes from the housings 1, 2, in this case simultaneously configured as a trigger element 50 and having a manual actuation element, which is a pretensioning actuation element. The trigger spring 7 is clamped between the outer needle holder 6 and a spring bearing 19 fixed to the housing and serving as a counter-bearing. The spring bearing 19 can be formed in one or both of the housing parts 1, 2. The outer needle 3 is fixedly connected at its proximal end to the outer needle holder 6, for example, by adhesive bonding. The inner needle 4 is guided through the lumen of the outer needle 3.

[0042] Figure 2 shows in a side view the biopsy needle device according to figure 1 in the assembled state. It can be seen that the displacement element 5 with the trigger element 50 protrudes from the housings 1,2 at the proximal end 10 thereof.

[0043] Additionally, the distal region of the biopsy needle device can be seen, having a tissue window 40 formed on the inner needle 4. Said distal region is further shown in enlarged form as detailed enlargement B of Figure 3. It can be seen that the tissue window 40 is configured as an elongated recess, i.e., the cross-sectional area of ​​the inner needle 4 is reduced in this region.

[0044] 4 shows the displacement element 5 in an enlarged detail view. It can be seen that the displacement element 5 has two longitudinal struts 52, 53 spaced apart from one another. At the proximal end, the longitudinal struts 52, 54 connect to the manual trigger element 50. At the distal end, the longitudinal struts 52, 53 connect to a transverse strut 57. The transverse strut 57 has a through-hole forming an outer needle guide 56, through which the outer needle 3 is displaceably guided. At or near the trigger element 50, the displacement element 5 may have an opening that serves as an inner needle receiver 59. The inner needle 4 can be fixed to said inner needle receiver 59.

[0045] The displacement element 5 functions as a tensioning device for tensioning the semi-automatic movement mechanism of the biopsy needle device. To do this, the trigger element 50 is grasped by the user and pulled proximally from the housings 1 and 2, causing the longitudinal struts 52 and 53 to emerge from the housings 1 and 2 and become visible. The user can observe the cutting length mark 54 on the displacement element 5, e.g., on the longitudinal strut 52, and select one of several pretensioning positions, e.g., from two different pretensioning positions, based on the cutting length mark 54. During this pretensioning movement, the outer needle holder 6, located in the internal space 51, is carried by the lateral strut 57 and, in the process, is pressed against the trigger spring 7, which is attached to a spring bearing 19 fixed to the housing. The trigger spring 7 is thus compressed and pretensioned to a relatively large extent.

[0046] Furthermore, an unlatching element 55 can be arranged on the displacement element 5, for example on the vertical post 53. By means of the unlatching element 55, the latching of the outer needle holder 6, which was previously carried out during tensioning, can be unlatched in case of trigger movement of the semi-automatic movement mechanism.

[0047] As previously mentioned, the manual operating element of the displacement element 5 functions as a pretensioning operating element during tensioning and then as a manually actuable trigger element 50 during triggering.

[0048] 5 shows an enlarged view of the outer needle holder 6. The outer needle holder 6 is guided by linear guide elements in the housings 1, 2. For this purpose, the outer needle holder 6 has a dedicated guide element 62 that is guided in at least one linear guide element of the housings 1, 2. Furthermore, the outer needle holder 6 has a receiving opening that forms an outer needle receiver 60 for receiving and fixing the outer needle 3. Furthermore, at least one first latch element 61 is arranged on the outer needle holder 6. In the illustrated exemplary embodiment, there are two first latch elements 61 that correspond to two different latch positions during the pretensioning movement according to the cutting length marks 54.

[0049] 6 shows the first housing part 1 in a side view. In the lower region there are attachment points 14 at which finger grip elements 8 are added on the housing parts 1, 2. Furthermore, the housing part 1 has a second latch element 12, for example in the form of an elastically deflectable latch tab, which can be realized, for example, by a U-shaped cutout introduced into the housing part 1, in which the latch tab is formed as part of the remaining material. The second latch element 12 interacts with the first latch element 61 of the outer needle holder 6 in order to secure the outer needle holder 6 in the desired latched position.

[0050] For clarity, FIG. 7 shows the first housing part 1 in a front view, i.e. a top view of the distal ends of the housings 1, 2.

[0051] Figure 8 shows the first housing part 1 from the opposite side to that of Figure 6, i.e., looking inwards. Next, the second latch element 12 can be seen, which is formed at its free end with a latch contour 13. The latch contour 13 interacts with the first latch element 61 of the outer needle holder 6 to form a latch.

[0052] In the exemplary embodiment, the first latch element 61 is described as a rigid portion on the outer needle holder 6, and the second latch element 12 is described as a resiliently deflectable portion. However, the assignment may be reversed, i.e., the first latch element 61 may be resiliently deflectable and the second latch element 12 may be rigidly disposed. The first and second latch elements 12, 61 may also each be resiliently deflectable. In the exemplary embodiment, the latch profile 13 is shown and described as a latch protrusion. The latch profile 13 may also be configured differently, for example, as a latch depression, a latch recess, or any other type of latch edge.

[0053] Also visible is a receiving element 15 which can receive a receiving pin of the finger grip element 8 in order to connect the finger grip element 8 to the housing parts 1, 2 in a form-fitting manner.

[0054] Additionally, the aforementioned second latch element 12 with latch contour 13 can be easily seen in the cross-sectional view of FIG.

[0055] Figure 10 clarifies the attachment of the finger grip element 8 to the housing part, using the example of the housing part 2, here shown in side view. The housing part 2 also has a receiving element 15. It can be seen that the finger grip element 8 has an annular finger receptor 80 with an inner recess 81. The inner recess 81 is dimensioned so that only one finger of the user can fit inside. On the side facing the attachment point 14, the finger grip element has a receiving pin 82 designed to be inserted into the receiving element 15 of the housing part 1, 2.

[0056] The biopsy needle device can be used as follows. First, the biopsy needle device must be pretensioned to either pretensioning position 1 or 2 according to the cutting length mark 54 by manually pulling out the displacement element 5 at the trigger element 50. During this process, one of the first latch elements 61 latches onto the second latch element 12. To extract a tissue sample within the biopsy area, the trigger element 50 is manually pressed. By this means, the displacement element 5 is already somewhat displaced distally. During this process, the second latch element 12 is somewhat deflected by the unlatching element 55, which unlatches the latch contour 13 of the outer needle holder 6 from the first latch element 61. From this point on, the outer needle holder 6 is automatically moved further distally by the trigger spring 7 due to the unlatching. In this way, the outer needle 3 is pushed into the tissue window 40 area of ​​the inner needle 4. The desired tissue sample is cut by the outer needle 3 and then stored in that area of ​​the tissue window 40 within the outer needle 3. The biopsy needle device can then be removed from the patient.

[0057] Figure 11 shows an embodiment of a biopsy needle device, in which the housing parts 1, 2, outer needle 3, inner needle 4, displacement element 5, outer needle holder 6 and trigger spring 7 can be configured substantially identically to the biopsy needle devices described above with reference to Figures 1 to 10. In contrast to the biopsy needle devices described above, Figure 11 provides an additional element, which allows external triggering of the pretensioned biopsy needle device, i.e., triggering at a distance, by an external actuator 9. For this purpose, the biopsy needle device can be configured with or without a finger grip element.

[0058] In the illustrated exemplary embodiment, no finger grip element is provided. Instead, a docking holder 16 configured to hold the external actuator 9 is integrally formed with the housings 1, 2. The external actuator 9 has a fixing element 90 that can be fixed to the docking holder 16, for example, in a form-fitting manner. A second trigger element 27, mounted so as to be displaceable transversely relative to the longitudinal axis of the outer needle 3, can be disposed within the docking holder 16. By applying a compressive force to the end of the second trigger element 27 remote from the displacement element 5, the displacement element 5 can be moved by the second trigger element 27 in the same distal direction as by direct manual pressure actuation of the trigger element 50 of the displacement element 5. An actuation plunger 92 is guided through the actuator 9 so that the second trigger element 27 can be remotely actuated. The actuator plunger 92 can be manually actuated at an end region 91 of the external actuator 9, which can also be manually held by a user. In order to deflect the direction of movement of the second trigger element 27 substantially perpendicular to the direction of movement of the displacement element 5, a ramp can be formed integrally with the second trigger element 27 in a manner similar to a ramp, thereby enabling this direction of movement to be converted.

[0059] 12 shows a further embodiment of a biopsy needle device in an exploded view. The biopsy needle device has a housing 1, 2 having a first housing portion 1 and a second housing portion 2. A finger grip element 8 fixedly connected to the housings 1, 2 is disposed on the housings 1, 2 at a proximal end 10. The finger grip element 8 can, for example, be integrally formed on one or both of the housing portions 1, 2.

[0060] Similarly, the biopsy needle device has a semi-automatic movement mechanism that substantially corresponds in design and function to the movement mechanisms of the other previously described embodiments. Next, there is the displacement element 5, the outer needle holder 6, and the trigger spring 7, as well as the outer needle 3 and the inner needle 4. The outer needle holder 6 serves to hold the outer needle 3, which is movably fixed thereon. Next, the outer needle holder 6 is guided at least partially within the internal space 51 of the displacement element 5. Next, the trigger spring 7 is clamped between the outer needle holder 6 and a spring bearing 19 fixed to the housing.

[0061] In contrast to the previously described embodiments, in the described embodiment, the displacement element 5 is manually operable by the user laterally on the housing 1, 2, rather than at the proximal end of the biopsy needle device. For this purpose, one or two finger grip elements 58 are integrally formed laterally on or connected to the frame-shaped body of the displacement element 5. The lateral finger grip elements 58 protrude laterally from the housing 1, 2 when the components are assembled. With this type of construction, the displacement element 5 can be moved back and forth only in the longitudinal region of the housing 1, 2, but does not protrude differently from the housing 1, 2 at its proximal end depending on the pretension position, as in the previously described embodiments. In this way, the overall length of the housing region of the biopsy needle device remains the same during use, regardless of the tension state.

[0062] The biopsy needle device described with reference to Figure 12 is further shown in a top view in Figure 13 and a side view in Figure 14. In Figure 13 it can be seen that different pretension positions can also be set here, which can be read by means of cutting length marks 20. The cutting length marks 20 can be provided, for example, on one of the housing parts 1, 2. The finger grip element 8 then has an annular finger receptor 80 with an inner recess 81. The inner recess 81 is dimensioned to accommodate only one finger of the user.

[0063] With reference to FIG. 14, it can be seen that the biopsy needle device is constructed identically to the embodiment described with reference to FIGS. 2 and 3 with respect to the outer needle 3, the inner needle 4 and in particular the tissue window 40.

[0064] 15 reveals the design of the displacement element 5 having a manual operating area with a finger grip element 58 which, combined with the trigger element 50, forms a pretensioning operating element. The finger grip element 58 can be configured with respect to the same design and dimensions as the finger grip element 8. The displacement element 5, in turn, has a frame-like design with an internal space 51 which forms a receiving space for the displacement element 5. The internal space 51 is surrounded by longitudinal struts 52, 53 which are connected at their distal ends by a transverse strut 57. The transverse strut 57 has an outer needle guide 56 for the passage of the outer needle 3.

[0065] The housing part 1 has a spring bearing 19 for the trigger spring 7 fixed to the housing. The longitudinal struts 52, 53 are guided laterally through the spring bearing 19. In the region between the proximal end 10 and the spring bearing 19, the housing part 1 has a second latch element 12, e.g., an elastically deflectable latch tab, on which a latch contour 13, e.g., a latch protrusion, is arranged. The latch contour 13 serves to latch the outer needle holder 6 in the respective desired latched position. On the displacement element 5, e.g., on one or both longitudinal struts 52, 53, there is a de-latch element 55 that contacts the release contour 18 of the second latch element 12 during the triggering action, deflecting the second latch element 12 downward and thus unlatching the latch contour 13 from the first latch element 61 of the outer needle holder 6. The de-latch element 55 can be arranged completely on the displacement element 5 below the outer needle receiver 59 and in each case laterally behind it.

[0066] 16 shows the outer needle holder 6 in a view in which the first latch element 61 is visible, which in this case is formed on the underside of the expansion area so as to be able to come into contact with the latch contour 13 of the housing part 1. For longitudinal guidance, the outer needle holder 6 has one or two guide elements 62, which guide element(s) are guided in the longitudinal struts 53 of the displacement element 5.

[0067] The function and operation of the biopsy needle device in this embodiment substantially correspond to the operation method already described above. In contrast, here, tensioning is performed via a manual operating area with a finger grip element 58, i.e., a different gripping and finger support method is possible than in the first embodiment. In contrast, the biopsy needle device described here can be gripped with three fingers and thus operated with one hand both during pretensioning and triggering. Thus, the finger grip element 58 also functions as a trigger element 50 for triggering the movement of the outer needle 3 relative to the inner needle 4, assisted by a trigger spring.

[0068] FIG. 17 shows an embodiment of a biopsy needle device and an external actuator 9 that serves to remotely trigger the trigger element 50 of the biopsy needle device. In contrast to the embodiment of FIG. 11, for example, the biopsy needle device according to FIG. 17 does not have a docking holder 16 for docking the external actuator 9. Instead, the external actuator 9 is formed in such a way that its fixing element 90 can nevertheless be fixed to the proximal end 10 of the biopsy needle device housing 1, 2, for example, by form-fitting and / or press-fitting. In this case, the external actuator 9 with the fixing element 90 can simply be pulled onto the proximal end 10 of the biopsy needle device. The biopsy needle device must be pretensioned to the desired pretensioned position beforehand. The trigger element 50 is then triggered, as in the embodiment of FIG. 11, by an actuating plunger 92, which is movable transversely to the longitudinal direction of the outer needle 3 and can be manually activated (by pushing) with the end of the external actuator. In this embodiment, the actuating plunger 92 acts directly mechanically on the trigger element 50. Therefore, in contrast to the embodiment of FIG. 11, a second separate trigger element 27 is not required.

[0069] Otherwise, the biopsy needle device according to FIG. 17 can be configured identically to one of the biopsy needle devices described above.

[0070] Figure 17 shows a further feature of the biopsy needle device, namely the embodiment of the finger grip element 8 as a notch or recess arranged laterally on the housing 1, 2. This is also advantageous for the ergonomic operation of the biopsy needle device.

[0071] Figure 18 shows an embodiment of the external actuator 9 in an exploded view. The external actuator 9 according to Figure 18 has a fixing element 90, which can be fixed by form-fitting and / or press-fitting at the proximal end of the housing of the biopsy needle device, as previously described. It can be seen that the external actuator 9 has a pistol grip in its end region 91, and an actuation plunger 92 is actuated by pushing the external actuator 9 forward. Here, the actuation plunger 91 can be actuated manually, for example by pressing it.

[0072] The pistol grip has the advantage of providing an ergonomically adapted handle for the user, thus minimizing the force to be applied while improving engagement accuracy. Furthermore, improved grip and stability are achieved in guiding and orienting the biopsy needle device.

[0073] It becomes clear that the pistol grip is arranged laterally in the end region 91 of the external actuator 9. However, it is also conceivable to arrange the pistol grip from above or below.

[0074] Otherwise, the external actuator 9 according to FIG. 18 can be designed equivalently to one of the external actuators 9 described above.

[0075] Figure 19 shows an embodiment of the biopsy needle device in an exploded view. In the case of the biopsy needle device according to Figure 19, in contrast to the embodiment of Figure 1, for example, the latch of the outer needle holder 6 is released via two second latch elements 12 designed to be latchable to the first latch elements 61, which are arranged inside the housing parts 1, 2. The first latch elements 61 are therefore no longer accessible from the outside and the housing parts 1, 2 in the attached state are closed on themselves.

[0076] It becomes clear that two first latch elements 61 protrude like wings from the outer needle holder 6. The second latch elements 12 can be configured, for example, as elastically deflectable webs, which interact with the first latch elements 61 of the outer needle holder 6 to secure the outer needle holder 6 in the desired latched position.

[0077] Figure 20 shows a side cross-sectional view of the biopsy needle device according to Figure 19. In the illustrated exemplary embodiment, it becomes clear that there are two second latch elements 12 arranged on opposite sides of the housing parts 1, 2. Here, the two second latch elements 12 are arranged at different positions in the longitudinal extension direction of the housing parts 1, 2, and by latching at least one of the first latch elements 61 to the corresponding second latch element 12, the outer needle holder 6 can be fixed in two different positions.

[0078] However, it is also conceivable that the two second latch elements 12 are arranged on only one of the housing parts 1, 2 at different positions in the longitudinal extension direction of the corresponding housing part 1, 2.

[0079] Furthermore, it can be seen that the housing parts 1, 2 in the mounted state are themselves closed, i.e. the second latch element 12 is no longer accessible from the outside, and in this way external influences on the latch can be reduced or avoided.

[0080] Otherwise, the biopsy needle device according to Figures 19 and 20 can be configured identically to one of the biopsy needle devices previously described. [Explanation of symbols]

[0081] 1 Housing part 2 Housing part 3 Outer needle 4 Inner needle 5 Displacement elements 6 Outer needle holder 7 Trigger spring 8 finger grip elements 9 External Actuators 10 proximal end of housing 11 Distal end of housing 12 Second latch element 13 Latch Contour 14 mounting points 15 Receptive Elements 16 Docking holder for external actuator 18 Release Contour 19 Spring bearings 20 Cutting length mark 27 Secondary Trigger Element 30 Penetration Depth Mark 40 Organizational Window 50 Trigger Elements 51 Interior Space 52 Vertical support 53 Vertical support 54 Cutting length mark 55 Unlatching element 56 Outer needle guide 57 Horizontal support 58 finger grip elements 59 Inner needle receptor 60 Outer needle receptor 61 first latch element 62 Guide Elements 80 Finger Receptors 81 Inner recess 82 Receptor pin 90 Fixed Elements 91 Edge area 92 Actuating plunger

Claims

1. A biopsy needle device having at least one hollow outer needle, an inner needle guided longitudinally movably within the outer needle, and a housing, the biopsy needle device having at least one manually actuable trigger element for triggering relative movement between the outer needle and the inner needle, and at least one finger grip element for holding and / or operating the biopsy needle device by at least one finger of a user; the biopsy needle device further comprises at least one pretensioning element, which can be used to bring about relative movement between the outer needle and the inner needle in a tension direction counteracting the force of a trigger spring of the biopsy needle device, the pretensioning element being a displacement element fixed to the inner needle, the outer needle being fixed to an outer needle holder disposed within an elongated internal space defined by the displacement element, and the trigger spring being disposed between the outer needle holder and a spring bearing defined by the housing; The biopsy needle device further comprises: a) the biopsy needle device has only one finger grip element, or the biopsy needle device has one or more finger grip elements that are asymmetrically positioned relative to the longitudinal axis of the outer needle; b) the biopsy needle device has at least one finger grip element at the proximal end of the housing; c) the biopsy needle device has exactly three finger grip elements; d) at least one finger grip element or an arrangement of at least two finger grip elements is displaceably mounted relative to the housing in the direction of the longitudinal axis of the outer needle; 10. A biopsy needle device comprising:

2. 2. The biopsy needle device according to claim 1, wherein at least one finger grip element or an arrangement of at least two finger grip elements is simultaneously configured as a trigger element.

3. 3. The biopsy needle device according to claim 1, wherein the pretensioning operating element is simultaneously configured as the trigger element for triggering relative movement between the outer needle and the inner needle, the relative movement being brought about by the force of the pretensioned trigger spring and in the opposite direction to the tensioning direction.

4. A biopsy needle device according to any one of claims 1 to 3, wherein the trigger element is defined by the displacement element.

5. 5. The biopsy needle device according to claim 1, further comprising a retaining mechanism which is used to retain the pretensioning operating element or a component connected thereto in at least one retaining position in relation to the force of the pretensioned trigger spring when the trigger spring is pretensioned.

6. 6. The biopsy needle device of claim 1, wherein one, a plurality of, or all of the finger grip elements have a ring shape, which can be configured as a circumferentially completely closed ring or as a ring that is open at one point.

7. 7. The biopsy needle device of claim 1, wherein one finger grip element, multiple finger grip elements, or all finger grip elements are configured as separate components rigidly or movably coupled to the housing.

8. 8. The biopsy needle device according to claim 1, wherein the single finger grip element of the biopsy needle device is positioned on the housing laterally offset relative to the longitudinal axis of the outer needle.

9. 9. The biopsy needle device according to claim 1, wherein the distance between the finger grip element located at the proximal end of the housing and the distal end of the housing is constant.

10. 10. The biopsy needle device according to claim 1, wherein the distance between the finger grip element arranged at the proximal end of the housing and the other finger grip elements of the biopsy needle device is at least 2 cm or at least 50% of the length of the housing of the biopsy needle device in all operating states of the biopsy needle device.

11. A biopsy needle device as described in any one of claims 1 to 10, characterized in that the at least one finger grip element includes a notch or recess disposed laterally on the housing.

12. A biopsy needle device as described in any one of claims 1 to 11, characterized in that the outer needle holder defines first and second latch elements that are respectively latchable to first and second latch elements defined by the housing.

13. A biopsy needle device as described in claim 12, characterized in that the first and second latch elements defined by the outer needle holder have a wing-like protruding shape.

14. A biopsy needle device as described in any one of claims 1 to 13, wherein the displacement element has first and second vertical pillars, and the internal space is defined between the first vertical pillar and the second vertical pillar.

15. The biopsy needle device of claim 14, wherein the displacement element further comprises a horizontal strut connecting the distal ends of the first and second vertical struts.

16. A biopsy needle device as described in claim 15, wherein the horizontal support has a through hole and the outer needle is arranged so as to be displaceable through the through hole.

17. A biopsy needle device having at least one hollow outer needle, an inner needle guided to be vertically movable within the outer needle, and a housing, the biopsy needle device having at least one manually actuable trigger element for triggering relative movement between the outer needle and the inner needle, and at least one finger grip element for holding and / or operating the biopsy needle device by at least one finger of a user; The biopsy needle device further comprises: a) the biopsy needle device has only one finger grip element, or the biopsy needle device has one or more finger grip elements that are asymmetrically positioned relative to the longitudinal axis of the outer needle; b) the biopsy needle device has at least one finger grip element at the proximal end of the housing; c) the biopsy needle device has exactly three finger grip elements; d) at least one finger grip element or an arrangement of at least two finger grip elements is displaceably mounted relative to the housing in the direction of the longitudinal axis of the outer needle; and a docking holder disposed on the housing of the biopsy needle device for holding an external actuator that allows the user to remotely activate the trigger element.

18. A biopsy needle device having at least one hollow outer needle, an inner needle guided to be vertically movable within the outer needle, and a housing, the biopsy needle device having at least one manually actuable trigger element for triggering relative movement between the outer needle and the inner needle, and at least one finger grip element for holding and / or operating the biopsy needle device by at least one finger of a user; The biopsy needle device further comprises: a) the biopsy needle device has only one finger grip element, or the biopsy needle device has one or more finger grip elements that are asymmetrically positioned relative to the longitudinal axis of the outer needle; b) the biopsy needle device has at least one finger grip element at the proximal end of the housing; c) the biopsy needle device has exactly three finger grip elements; d) at least one finger grip element or an arrangement of at least two finger grip elements is displaceably mounted relative to the housing in the direction of the longitudinal axis of the outer needle; a biopsy needle device comprising at least one of: an external actuator that allows the user to remotely activate the trigger element of the biopsy needle device; A set consisting of:

19. 19. The set according to claim 18, characterized in that the external actuator has at least one fixation element by means of which the external actuator can be fixed to the biopsy needle device in a form-fitting and / or press-fit manner.

20. 20. The set according to claim 18 or 19, wherein the external actuator has an actuation plunger for remote actuation of the trigger element of the biopsy needle device, the actuation plunger being longitudinally movable in a direction extending transverse to the longitudinal axis of the outer needle.

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