Biopsy device, assistance method, and biopsy instrument

Abstract

The invention relates to a biopsy device (1) for performing a biopsy on a female breast (10), comprising:-an imaging device (2) for tomosynthesis of the breast (10), which imaging device has a pressing device (43) for fixing the breast (10); -a handheld biopsy instrument (3) with a biopsy needle, wherein the biopsy instrument (3) has an orientation sensor (12) for measuring orientation information showing an orientation of the biopsy needle (8); -a marking device (6) registered with the imaging device (2) for: marking an entry point for the biopsy needle (8) on the breast (10) fixed in the pressing device (43) on the basis of plan information for the biopsy to be performed on the basis of image data of the imaging device (2); -an output device (5) for outputting guidance information for a person performing the biopsy, said guidance information showing a relative orientation of the biopsy needle (8) with respect to a desired orientation (41) with respect to the planning information, as a function of the orientation information, and-; and a control device (4) for controlling the biopsy device (1) according to the planning information.

Description

Technical Field

[0001] The invention relates to a biopsy device for performing a biopsy on a female breast, the biopsy device having an imaging device for tomosynthesis of the breast, the imaging device having a compression device for immobilizing the breast, a method for assisting a person performing a biopsy with the aid of the biopsy device and a biopsy instrument. Background Art

[0002] Biopsies are usually performed in the female breast (mammary gland) or at other sites of the human body in order to more precisely examine anatomical abnormalities, in particular tissue changes, and thus to be able to make a diagnosis. This is because medical imaging, such as breast tomosynthesis, is usually not sufficient to make a final diagnosis. During a biopsy, a biopsy needle is used as a medical instrument in order to be able to reach the site of interest in the least invasive manner possible and to extract a tissue sample there. For example, the so-called puncture biopsy method is known for this purpose.

[0003] In biopsy, the area of ​​interest in the patient's body should be hit as accurately as possible, which means that the biopsy needle must be positioned in three-dimensional space with sufficient positioning accuracy. For this reason, the biopsy device usually has an imaging device, usually an X-ray device. In many cases, in order to be able to screen at the biopsy device, the imaging device involves a tomography device. Here, many requirements are put forward for the biopsy device. In terms of imaging, image artifacts caused by the biopsy needle and the components of the biopsy unit containing the biopsy needle during X-ray recording should be avoided as much as possible, not only in two-dimensional X-ray recording but also in three-dimensional X-ray recording, especially tomography recording. The biopsy instrument and other components to be positioned close to the patient should require as little construction space as possible on the object table and at the object table, so as not to limit contact with the female patient and the examination area. The treatment duration should be as short as possible. For example, this means that the motor-type positioning drive should be of short duration. Finally, low weight and low cost are expected.

[0004] In the prior art, designs of biopsy devices have been proposed in which a biopsy unit with an actuator for positioning and moving a biopsy needle is fastened to an object table and / or to a support of an imaging device. The entire biopsy unit is registered with the coordinate system of the imaging device in this case, so that planning information obtained with the aid of image data of the imaging device can be directly converted into the control of the actuator, which is in particular designed as an electric motor, in order to perform tissue extraction fully automatically.

[0005] However, the disadvantages of this design are as follows: Such fixedly mounted or fixedly mountable biopsy units are complex, take up a large amount of structural space and must be implemented in a highly complex manner in a reliable and robust manner so that the site of interest is reached with sufficient precision. In addition, acceptance is partially limited in female patients because the biopsy is performed fully automatically without the assistance of a trustworthy person. Summary of the invention

[0006] The invention is therefore based on the object of providing a biopsy device which, despite its relatively low-cost, space-saving realizability, nevertheless allows a highly precise biopsy in a simple manner.

[0007] In order to achieve the object, a biopsy device, a method and a biopsy instrument are proposed according to the present invention. Advantageous designs are described below.

[0008] According to the present invention, a biopsy device for performing a biopsy at a female breast comprises:

[0009] - an imaging device for tomosynthesis of the breast, the imaging device having a compression device for immobilizing the breast,

[0010] - a handheld biopsy instrument having a biopsy needle, wherein the biopsy instrument has an orientation sensor for measuring orientation information indicating the orientation of the biopsy needle,

[0011] a marking device registered with the imaging device for marking an entry point for a biopsy needle on the breast fixed in the compression device according to planning information for the biopsy to be performed based on the image data of the imaging device,

[0012] - an output device for outputting guidance information for a person performing the biopsy, the guidance information showing the relative orientation of the needle according to the position information relative to the desired orientation according to the planning information, and - a control device for controlling the biopsy device according to the planning information.

[0013] In this case, the position sensor is designed to record sensor data describing the orientation of the biopsy needle in three dimensions. The position sensor can be a gyroscopic sensor in particular, but can also be designed in another way.

[0014] According to the invention, it is therefore proposed that a hand-held biopsy instrument containing a biopsy needle and having an orientation sensor is combined with a marking device so that the biopsy needle for extracting a tissue sample can be positioned in a space-saving and cost-effective manner, but still with high precision, based on planning information based on image data of an imaging device. In this case, an output device is used, which informs the person performing the biopsy so that the biopsy needle can be oriented according to the desired orientation. The information about the desired entry point is known by means of the marking device.

[0015] In this way, the biopsy device can be realized very cost-effectively and conveniently, since no motors, power electronics or movable axes and / or precision guides are required. The biopsy instrument can be realized with very low weight, so that it can be easily guided by the person performing the biopsy, in particular for setting the desired orientation. Since the hand-held biopsy instrument can be kept away from the subject table and does not have to be fastened to the subject table or to a stand, as is the case with highly complex, heavy biopsy units of the prior art, there are almost no structural space restrictions compared to a separate imaging device, and the female patient can be approached completely freely. At the same time, there is a high sense of safety for the female patient, since the operation is performed by the person manually.

[0016] Rapid sample extraction, for example in the case of ultrasound-guided biopsies, is also possible. Since no biopsy unit has to be installed, there is no need for assembly work between screening and biopsy. In this context, it should be noted that the proposal according to the invention also allows existing imaging devices, in particular mammography devices, to be retrofitted in a simple manner to form a biopsy device, since ultimately only the marking device and the handheld biopsy device have to be added. Control devices, displays, etc. are usually already present.

[0017] In concrete operation, when there is planning information that can describe, for example, the desired path of the biopsy needle, the entry point is always transmitted to the marking device or the marking device is actuated as a function of the entry point to mark the entry point. In other words, the control device can be designed as a whole to transmit the entry point to the marking device and / or actuate the marking device as a function of the entry point.

[0018] In particular, the marking device can have a marking laser. That is to say, it is conceivable that the entry point is marked by light on the surface of the female patient. The use of a laser is preferred for this purpose, because the laser can be easily identified, but other types of projection devices can also be used. Exemplary laser devices that can be used are described, for example, in the publication "Integrationeines Projektors zur Einblendung von Positionier-und Untersuchungshilfen", in Prior Art Journal 2020 #05, Volume 99, Pages 119-122, ISBN: 978-3-947591-33-6.

[0019] The marking device can be expediently arranged at the imaging device. By arranging the marking device at the imaging device, the alignment is provided in a particularly simple manner. Specifically and particularly preferably, the marking device can be arranged at a radiator unit comprising an X-ray radiator of the imaging device or integrated into the radiator unit. It is known in mammography devices and known biopsy devices to use an X-ray detector with a cover itself as an object table, wherein the breast can be pressed and held in place by means of additional pressure plates (also called pressure wings) above. The X-ray radiator is movably arranged in the radiator unit above the object table and the pressure plate in the case of possible tomosynthesis, and the desired entry position can be marked in a manner extending therefrom.

[0020] In this context, it is also particularly advantageous if the pressure device has a pressure plate for pressing the upper part of the breast, in particular facing away from the X-ray detector of the imaging device, wherein the pressure plate has at least one through-opening for the insertion of the biopsy needle. As already mentioned, the lower part of the breast is preferably placed on a detector cover of the X-ray detector, which forms the object table. That is, an upper pressure plate is used, which allows access to the breast at least in the area defined by the through-opening, in particular at least one window. The through-opening can be used on the one hand to project an entry point, preferably from above as mentioned, and on the other hand to gain access to the biopsy needle of the biopsy device. In a specific embodiment, it can be provided that the pressure plate has a plurality of through-openings arranged in a matrix. Such a pressure plate can also be referred to as an "alphanumeric pressure plate", because a "chessboard pattern" can be provided for the through-openings, and the individual through-openings can be identified by letters (for one direction) and numbers (for the other direction).

[0021] In a further development of the invention, it can be provided that the invention has a holding device for the biopsy instrument, in particular a holding device arranged at the imaging device. For example, the holding device can be arranged laterally at the imaging device, in particular at the support of the imaging device, but other arrangement positions are also conceivable. As soon as the biopsy instrument is no longer needed, for example when the imaging device is used for screening, the biopsy instrument can be stored in the holding device. The holding device can be used for various other functions as desired.

[0022] Therefore, it can be specifically provided that the holding device is designed to establish a predetermined calibration orientation of the biopsy instrument in order to calibrate the position sensor. This can be achieved, for example, by virtue of the shape and / or by virtue of a correspondingly selected support surface. In particular, the holding device can be designed such that the biopsy instrument can only be inserted into the holding device with an exact fit in a specific calibration orientation. That is, when the biopsy instrument is inserted into the holding device, the position sensor can always be recalibrated, so that the position information can always be determined in a clearly defined manner in registration with the imaging device.

[0023] The holding device also has an electrical interface for charging the energy storage device of the biopsy device. In this case, the interface can, for example, include a connection mechanism on the holding device side, which interacts with a connection mechanism on the biopsy device side. In particular, when the biopsy device is inserted into the holding device, an electrical connection is also directly established for charging the energy storage device. In this regard, the holding device can also be understood as a "charging shell".

[0024] In general, it is expedient for the biopsy instrument to be wirelessly designed, i.e., no connecting cables are required that could interfere and / or get in the way during the biopsy. Specifically, it can be provided that, in addition to the energy storage device, the biopsy instrument has a communication device for wireless communication with the control device. The communication device can be, for example, a Bluetooth device.

[0025] Preferably, the biopsy instrument can have a control unit, which can communicate with the control device via the communication device, in particular bidirectionally. The control unit controls the operation of the biopsy instrument. The control unit can be designed in particular to determine the position information from the sensor data of the position sensor, and

[0026] - forwarding the position information or information derived therefrom to a control device (external to the biopsy device) by means of a communication device, and / or

[0027] - Ascertaining the deviation of the orientation of the biopsy needle from the desired orientation which has been determined via the communication device.

[0028] In this case, it is particularly useful for the control device to communicate information about the current position information and to recognize the desired orientation. Because, as will be shown in more detail below, it is then conceivable to ultimately implement the output device in a distributed manner in order to assist the person performing the operation in various ways with the aid of auxiliary instructions as guidance information.

[0029] In a particularly preferred embodiment of the present invention, it is proposed that the biopsy instrument has an output mechanism of an output device, which is designed to output auxiliary instructions in relation to the relative orientation of the biopsy needle relative to the desired orientation according to the position information. If the output mechanism is directly arranged at the biopsy instrument, the person performing the biopsy does not have to divert his attention from the biopsy instrument and the surgical field, in particular also from the marked entry point, so that he can focus his attention completely on the surgery in a simplified manner. In this case, if the deviation from the desired orientation is determined inside the biopsy instrument as described above, the control of the output mechanism can be carried out directly by the above-mentioned control unit in a targeted manner. That is, in this case, it is only necessary for the control device to provide the biopsy instrument with the desired orientation, for which a communication device can be used so that the biopsy instrument can autonomously guide the person performing the biopsy to assume the desired orientation by a corresponding output via the output mechanism, while the entry point is displayed externally by a marking device registered with the imaging device.

[0030] Particularly preferably, the output mechanism can be a tactile output mechanism. Specifically, the tactile output mechanism can be a vibration motor. In this way, the person performing the operation can also focus on the actual biopsy area, especially the entry point and the biopsy needle, because the output mechanism is aimed at other senses. Because the biopsy instrument is handheld, the vibration can be well felt. In addition or alternatively, the output mechanism can also be an acoustic output mechanism. Optical output mechanisms can also be considered, but at least individually they are not so preferred. In principle, it is conceivable that feedback is always provided when the biopsy needle is in the desired orientation. However, it is preferred to use feedback via an output mechanism, especially a tactile output mechanism, so as to gradually guide the person performing the biopsy to the desired orientation.

[0031] Therefore, in a specific, advantageous design, the output mechanism can be controlled according to a target area to be set around the desired orientation, which becomes smaller over time, so as to gradually guide the person performing the biopsy to the desired orientation. That is, the control unit can be configured in particular to perform the control. In other words, it is proposed to switch from a large "capture range" to a smaller "capture range". In this case, it can be specifically proposed that the output mechanism is activated when leaving the target area. This means that when the person performing the biopsy is about to leave the target area, the person is always guided back to the target area through corresponding feedback. Therefore, as the target area becomes smaller and smaller over time, the desired orientation is occupied more and more accurately, in that it is first guided to a rough target area, which then gradually shrinks. Therefore, a particularly intuitive target guidance to the desired orientation is provided.

[0032] Other schemes for the specific use of the output mechanism can also be considered. For example, in the case of an acoustic output mechanism, the user is guided to the desired orientation in a "parking assistance" manner by emitting sounds spaced apart in time when the distance to the desired orientation is large, and the time intervals of the sounds gradually become smaller until a passing sound is emitted when the desired orientation is reached.

[0033] Alternatively or preferably, it can be provided that the output device includes a display, wherein a control device for controlling the display is controlled to output a view that visualizes the relative orientation of the needle relative to the desired orientation according to the position information. That is, the view then forms the guidance information. In this case, for example, a display that is also used by the imaging device to show image data, etc. can be used. The display can also be a touch screen, which can additionally be used as an input device. Preferably, the display is arranged or can be arranged in the field of vision of the person performing the biopsy, for example by means of an adjustable holding device, such as a holding arm.

[0034] In this case, the display is preferably directly controlled by a control device, which receives the position information of the biopsy instrument by means of a communication device. The graphic view can contain, in particular, an abstract and / or schematic view of the biopsy needle in the current orientation described by the position information in comparison with the desired orientation shown by the additional elements. The view can be obtained, for example, as a superposition of image data, in particular such image data on which the planning information is based. However, abstraction is also possible with regard to the background, in particular, because the current actual spatial position of the biopsy needle (as opposed to its orientation) is generally unknown, so that confusion can be avoided.

[0035] The biopsy device can also have a planning device for at least partially automatically determining planning information from the image data of the imaging device. In this case, for example, a two-dimensional or three-dimensional localizer scan can be recorded by means of the imaging device, which localizer scan can be evaluated at least partially automatically by the planning device, which can include, for example, a workstation. For example, a planning user interface can be displayed on a display device of the workstation via which a user can manually intervene in the planning, for example, can mark areas of interest, etc. The planning process and the general method for determining planning information are already widely known in the prior art and are therefore not described in detail here.

[0036] Preferably, the biopsy needle, in particular along the needle shaft, can have a marking in order to display the penetration depth into the female patient. Thus, markings can be provided at regular intervals along the needle shaft of the biopsy needle so that the current penetration depth can be easily read out by the person performing the biopsy. The expected penetration depth according to the planning information can be output for reference, for example, by means of an output device, in particular a display. In addition to the parameters, namely the entry point and the expected orientation, it is also possible to monitor and check the expected penetration depth by means of such markings. It should be noted here that, alternatively or additionally, if a corresponding detection device is provided in the biopsy instrument, the current penetration depth can also be output at one or more output devices of the biopsy instrument. In principle, it is also conceivable to provide an actuator in the biopsy instrument for automatically removing the biopsy needle, but this is less preferred because, as mentioned, the actuator is preferably avoided in order to be able to handle the biopsy instrument in an operable and easy manner.

[0037] In addition to the biopsy device, the present invention also relates to a method for assisting a person who performs a biopsy with the biopsy device according to the invention, wherein an output device is controlled to output guidance information, which displays the relative orientation of the needle according to the position information relative to the desired orientation according to the planning information. All embodiments of the biopsy device according to the invention, in particular with regard to the communication, the control by the control device and the control unit and the specific design of the output device, can be transferred analogously to the method according to the invention, so that the advantages already mentioned can also be achieved with the method.

[0038] Finally, the present invention also relates to a hand-held biopsy instrument for a biopsy device according to the invention, the biopsy instrument having a biopsy needle and an orientation sensor for measuring orientation information indicating the orientation of the biopsy needle. The embodiments concerning the biopsy device and concerning the method, as far as applicable, also apply analogously to the biopsy instrument. Therefore, the biopsy instrument can in particular also have a control unit, a battery, a communication device and / or a connection device for charging the battery. However, it is particularly preferred that the biopsy instrument has an output device, which, as described above, can be controlled in particular by the control unit in order to display a relative orientation or deviation relative to a desired orientation, in particular obtained via the communication device, for example based on a target area around the desired orientation that becomes smaller over time. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Further advantages and details of the invention are apparent from the exemplary embodiments described below and from the accompanying drawings. They are shown here:

[0040] Figure 1 A simplified diagram showing the functional components of a biopsy device according to the invention,

[0041] Figure 2 A stereoscopic view showing a biopsy instrument,

[0042] Figure 3 A view showing a portion of an imaging device,

[0043] Figure 4 Showing the pressing plate,

[0044] Figure 5 A graphic for explaining the operation of the output mechanism is shown, and

[0045] Figure 6 Possible visual views on a display are shown. DETAILED DESCRIPTION

[0046] Figure 1 The functional structure of the biopsy device 1 according to the present invention is shown. As main components, the biopsy device 1 includes an imaging device 2, which is not listed in detail here, a handheld wireless biopsy instrument 3, a control device 4, an output device 5 which is currently divided into multiple components, and a marking device 6, which is currently fastened to the imaging device 2 or integrated in the imaging device 2. In addition, the biopsy device 1 currently also includes a planning device 44, which can be configured as a workstation, for example.

[0047] The planning device 44 is designed to carry out planning at least partially automatically based on the image data of the imaging device 2, that is, in the present case an X-ray device for tomosynthesis of the female breast, in which the user can also participate. The result of the planning is planning information, which in particular specifies how the biopsy needle 8 of the biopsy device 3, which is fastened there by means of a needle holder 9, is to reach the interesting region of the breast 10 currently to be treated, which is schematically indicated here, from which a tissue sample is to be extracted. In other words, the planning information describes in particular the desired entry point, the desired orientation and also the desired penetration depth of the biopsy needle 8. The planning information is provided to the control device 4.

[0048] The control device 4 now forwards the entry point to a marking device 6 which has a marking laser 7 and is registered with the imaging device 2, the planning information also relating to the coordinate system of the imaging device 2. The marking device 6 can thus project the entry point according to the dashed arrow 11 onto the breast 10 with high precision for the person performing the biopsy.

[0049] In order to also be able to correctly set the desired orientation, the biopsy instrument 3 has an orientation sensor 12, such as a gyroscopic sensor, which can measure the current orientation of the biopsy instrument 3 in all three spatial directions. The sensor data of the orientation sensor 12 are evaluated into orientation information by a control unit 13 of the biopsy instrument 3. The biopsy instrument 3 can communicate wirelessly with the control device 4 via a communication device 14, as indicated by an arrow 15. At present, the communication device 14 is configured as a Bluetooth module, and the control device 4 has a Bluetooth function. The control unit 13 obtains the desired orientation provided by the control device 4 via the communication device 14, so that the control unit 13 can determine the deviation of the current orientation of the biopsy instrument 3 and thus the biopsy needle 8 from the desired orientation. At the same time, the control unit 13 can provide the control device 4 with orientation information via the communication device 14.

[0050] The control device 4 and the control unit 13 use various components of the output device 5 in order to provide the person holding the biopsy instrument 3 and performing the biopsy with auxiliary instructions as guidance information, which guides the person to assume the desired orientation with the biopsy needle 8 .

[0051] In particular, the biopsy device 1 firstly generally has a display 16 as part of the output device 5, on which a graphical view visually shows potential deviations from the desired orientation. On the part of the control device 4, such a view can be easily generated based on the position information.

[0052] As a further component of the output device 5, the biopsy instrument 3 also has an output mechanism 17, in the present case a tactile output mechanism designed as a vibration motor. As a result, auxiliary instructions can be output directly and without the person having to look away from the operating area, as will be explained in more detail below. The auxiliary instructions are output as a function of the deviation from the desired orientation determined by the control unit 13.

[0053] In the present case, the control unit 13 is designed as a microcontroller and has a firmware which performs the described functions.

[0054] In order to be able to supply electrical energy to the components of the biopsy instrument 3, the biopsy instrument 3 also has a rechargeable energy storage device 18, such as a battery. Due to the wireless communication via the communication device 14 and the integrated electrical energy supply, the biopsy instrument 3 is cable-free.

[0055] When not needed, the biopsy instrument 3 can be stored in a holding device 19, which can be arranged, for example, on a support of the imaging device 2. The holding device is designed so that the biopsy instrument 3 can only be inserted into the holding device 19 in a predetermined calibration orientation. That is, when the biopsy instrument 3 is inserted into the holding device 19, the orientation sensor 12 can always be recalibrated, since the calibration orientation is then known. This can be determined, for example, by also forming a connection between the connecting means 20 of the biopsy instrument 3 and the connecting means 21 of the electrical interface 22 for charging the energy store 18 on the holding device 19, which preferably occurs automatically when the biopsy instrument 3 is inserted into the holding device 19.

[0056] Figure 2 A three-dimensional diagram of a possible design of the biopsy instrument 3 is shown. Figure 1 The components shown in FIG. 2 are accommodated in a housing 23, which may have an operating mechanism 24, such as a handle, to improve the operation of the biopsy instrument 3. Figure 2 As can also be seen in FIG. 1 , markings 25 are provided at regular intervals along the needle axis of the biopsy needle 8 , at which the penetration depth of the biopsy needle 8 into the breast 10 can be read, also with reference to arrow 26 ( Figure 1 ).

[0057] Since the desired penetration depth is also displayed on the display 16, it can therefore also be easily observed by the person performing the biopsy. On the biopsy device 3, further output means for displaying the desired penetration depth can also be provided.

[0058] Figure 3 The illustration shows an imaging device 2, in the present case an X-ray device for tomosynthesis of a breast 10. The imaging device 2 thus comprises a support 27, on which a radiator unit 28 with an X-ray radiator 29 and an X-ray detector 30 with a cover 31 as an object table 32 are arranged. An upper, movable pressure plate 33 forms a pressure device 43 for the breast 10 together with the detector 30 and its cover 31.

[0059] In order to be able to perform a biopsy through the compression plate 33 (also commonly referred to as the compression wing), as Figure 4 As shown in the top view in FIG. 1 , the pressure plate 33 has through-openings 34, which are arranged in a matrix-like manner in the present case. The planning information can indicate which through-openings 34 are to be used. The through-openings 34 also allow the entry point to be projected onto the surface of the breast 10 according to the dashed arrow 11. The through-openings 34 also allow the biopsy needle 8 to be introduced into the breast 10 (dashed arrow 26).

[0060] In order to carry out a specific biopsy according to the planning information, it can now be provided, for example, that the control device 4 transmits the entry point to the marking device 6 and actuates the marking device 6 to project the entry point onto the surface of the breast 10. The person performing the biopsy can now hold the biopsy instrument 3 in his hand and place the biopsy needle 8 onto the entry point or introduce it slightly into the entry point. The person then uses the auxiliary indications of the output device 5 to assume the desired orientation and then uses the marking 25 of the biopsy needle 8 to select the correct penetration depth corresponding to the desired penetration depth.

[0061] about Figure 5 and Figure 6 A specific variant is described for assisting the person performing the biopsy when the desired orientation is assumed. The two variants are preferably implemented in a complementary manner.

[0062] The first variant uses the tactile output mechanism 17 of the biopsy instrument 3. In this regard, Figure 5 The time curve is shown along the horizontal axis 35, and the deviation of the current orientation of the biopsy needle 8 from the desired orientation is shown along the vertical axis 36. The solid line graph 37 shows the time curve of the setting made by the person performing the biopsy, while the dashed line graph 38 shows the curve of the target area narrowed over time around the desired orientation (i.e. the deviation is zero). When the deviation reaches the edge of the target range (reference point 39), tactile feedback is always output via the output device 17, so that as can be seen from the curve 37, the user is guided intuitively and naturally over time to the desired orientation in a manner from a coarse setting to a fine setting.

[0063] Figure 6 A possible visual graphical representation 40 is shown on the display 16. With the position information, the position of the biopsy needle 8, shown here in a basic structure, relative to the desired orientation 41 indicated by the dashed line can be displayed. The visual representation 40 can be updated in real time and can also be supplemented by other elements, in particular here also by a display device 42 of the desired penetration depth, which is only indicated schematically. The representation 40 can be designed in color.

[0064] Although the details of the present invention have been described in detail through the preferred embodiments, the present invention is not limited to the disclosed examples, and other variations can be derived by those skilled in the art without departing from the scope of protection of the present invention.

[0065] Includes persons having either male or female identities, regardless of the grammatical gender of a particular term.

Claims

1. A biopsy device (1) for performing a biopsy on a female breast (10), the biopsy device (1) comprising: - an imaging device (2) for tomosynthesis of the breast (10), the imaging device having a compression device (43) for immobilizing the breast (10), - a handheld biopsy instrument (3) having a biopsy needle, wherein the biopsy instrument (3) has an orientation sensor (12) for measuring orientation information indicating the orientation of the biopsy needle (8), - a marking device (6) registered with the imaging device (2), the marking device being used to mark an entry point for the biopsy needle (8) on the breast (10) fixed in the compression device (43) according to planning information for the biopsy to be performed based on the image data of the imaging device (2), - an output device (5) for outputting guidance information to a person performing the biopsy, the guidance information showing the relative orientation of the biopsy needle (8) according to the position information relative to the desired orientation (41) according to the planning information, and - A control device (4) for controlling the biopsy device (1) according to the planning information.

2. The biopsy device (1) according to claim 1, characterized in that: The marking device (6) has a marking laser (7) and / or the marking device (6) is arranged on the imaging device (2).

3. The biopsy device (1) according to claim 1 or 2, characterized in that: The pressing device (43) has a pressing plate (33) for pressing the upper part of the breast (10), wherein the upper pressing plate (33) is particularly facing away from the X-ray detector (30) of the imaging device (2), and the upper pressing plate (33) has at least one through-opening (34) for passing the biopsy needle (8).

4. The biopsy device (1) according to any one of the preceding claims, characterized in that The biopsy device (1) has a holding device (19) for the biopsy instrument (3), wherein the holding device (19) is arranged in particular on the imaging device (2).

5. The biopsy device (1) according to claim 4, characterized in that: The holding device (19) is designed to establish a predetermined calibration orientation of the biopsy instrument (3) for calibrating the position sensor (12), and / or the holding device (19) has an electrical interface (22) for charging an energy storage device (18) of the biopsy instrument (3).

6. The biopsy device (1) according to any one of the preceding claims, characterized in that The biopsy instrument (3) has a communication device (14) for wirelessly communicating with the control device (4).

7. The biopsy device (1) according to any one of the preceding claims, characterized in that The biopsy instrument (3) has an output mechanism (17) of the output device (5), and the output mechanism (17) is configured to output auxiliary indications in a manner related to the relative orientation of the biopsy needle (8) relative to the desired orientation (41) based on the position information.

8. The biopsy device (1) according to claim 7, characterized in that: The output mechanism (17) is a tactile output mechanism (17).

9. The biopsy device (1) according to claim 6 or 7, characterized in that: The output mechanism (17) can be controlled based on a target area to be set around the desired orientation (41) which becomes smaller over time, so as to gradually guide the person performing the biopsy to the desired orientation (41).

10. The biopsy device (1) according to claim 9, characterized in that When leaving the target area, the output mechanism (17) is activated.

11. The biopsy device (1) according to any one of the preceding claims, characterized in that The output device (5) comprises a display (16), wherein the control device (4) for operating the display (16) is operated to output a view (40) which visualizes the relative orientation of the biopsy needle (8) relative to the desired orientation (41) according to the position information.

12. The biopsy device (1) according to any one of the preceding claims, characterized in that The biopsy device (1) also has a planning device (44) for at least partially automatically determining the planning information from the image data of the imaging device (2).

13. The biopsy device (1) according to any one of the preceding claims, characterized in that The biopsy needle (8) has markings (25) particularly along the needle shaft to indicate the penetration depth into the female patient.

14. A method for assisting a person performing a biopsy with the aid of a biopsy device (1) according to any one of the preceding claims, wherein the output device (5) is controlled to output guidance information, which displays the relative orientation of the biopsy needle (8) according to the orientation information relative to the desired orientation (41) according to the planning information.

15. A handheld biopsy instrument (3) for use with the biopsy device (1) according to any one of claims 1 to 13, the biopsy instrument (3) comprising a biopsy needle (8) and an orientation sensor (12) for measuring orientation information indicating the orientation of the biopsy needle (8).

Images