WO2015044071A1

WO2015044071A1 - Biopsy device

Info

Publication number: WO2015044071A1
Application number: PCT/EP2014/070091
Authority: WO
Inventors: Marcus RADICKE
Original assignee: Siemens Aktiengesellschaft
Priority date: 2013-09-24
Filing date: 2014-09-22
Publication date: 2015-04-02
Also published as: DE102013219133A1

Abstract

The invention relates to a biopsy device and to a method for controlling a biopsy, comprising reading (S12) position data of a lesion from at least one first recording from a first imaging method, fixing the tissue area (2) having the lesion to be examined on a fixing plate (4), creating a second recording as a real-time image by using a second imaging method, at least in the area of the lesion, wherein the real-time image has the same recording geometry of a recording geometry of the first recording, localizing (S14) the lesion in the real-time image on the basis of the position data read, and generating position control data, displaying the real-time image with the localized lesion and controlling the biopsy device (3) by using the position control data generated.

Description

description

BIOPSY DEVICE Field of the Invention

The invention relates to a device for assisting and controlling a biopsy and a method for preparing and supporting the biopsy.

State of the art

The early detection of breast cancer is a huge challenge for all imaging techniques that currently exist. Currently, diagnoses are performed based on different imaging techniques. In comparison to a diagnosis based on only one imaging method, diagnoses with higher sensitivity and specificity can be obtained by combining several imaging methods. However, despite the combination of different imaging techniques lesions can not be classified reliably at times, so that a tissue removal is necessary. However, the coordinates of the lesion are currently known only from one method, for example from an ultrasound or X-ray imaging method. An X-ray-based biopsy can not be performed during the biopsy due to the radiation exposure just in an in vivo examination, ie the examination of a patient. However, in order to perform an image-assisted biopsy, hand-held ultrasound is used so that the biopsy can be supported by real-time images. One difficulty is that the person performing the biopsy needs both hands. One for the guidance of the ultrasound, the other for the removal of the biopsy. Or there may be several people present who can do the biopsy. In addition, it is sometimes difficult for a person skilled in the art to unambiguously recognize the lesion in the ultrasound image because the ultrasound images are in another Recording geometry are recorded and are therefore not directly comparable.

Presentation of the invention

The object of the invention is therefore to provide a device, a system and a method which can improve, support and simplify the performance of a biopsy.

The object is achieved by a method according to claim 1 and a device according to the enclosed device claim. Further, the invention ausgestaltende features are included in the subclaims.

A method for preparing and supporting a biopsy comprises the steps of reading position data of a lesion from a first imaging procedure (usually X-ray based), optionally: preparing the tissue area with the lesion, forwarding the read position data to a second recording device (in particular an ultrasound device) and Generating a real-time image in a recording geometry that corresponds to the recording geometry of the first image (ie the image from which the position data of the lesion are read in). The method preferably comprises the further method step: displaying the lesion in the real-time image. Furthermore, the method comprises the automatic or semi-automatic (ie verified by the user) driving a biopsy device with the data sets (namely leslie the lesion) from the two images (first image: preferably X-ray and second image: preferably ultrasound) of different modalities. For this purpose, the position control data are used which, as described above, have been obtained on the two data sets by the different imaging methods or have been read from a memory. The preparation of the tissue area relates in particular to a diagnosis of breast cancer, the clamping or compression of the breast to be examined and the fixation of the tissue area to be examined (eg by gauze), so that an image of this tissue area can be generated with an image process.

In this case, recording geometry refers to the position of the images produced. A matching recording geometry here means that the tissue to be examined experiences only slight or ideally no deformation between the images. The fact that the position data in the lesion are known from a first imaging method (imaging method can be, for example, an ultrasound method or an x-ray method) and the real-time image, which is preferably generated by an ultrasound imaging method, is generated in the same imaging geometry reliably allows conclusions to be drawn to the position of the lesion in the real-time image. In particular, if different imaging methods for the real-time image and the recording are used for the position data determination, the acquisition geometry is important. For example, ultrasound and X-ray methods produce different image planes when picked up from the same direction. By the same recording geometry, the lesion can therefore be easily recognized by the attending physician and thus allows a good monitoring of the biopsy to be performed. If the same imaging methods are used for the position data and the real-time image, the detection of the lesion in the real-time image is even easier. This is especially true when the real-time image shown is in the same image plane that had the image from which the positional data of the lesion were obtained. However, if the real-time image is generated using a different imaging technique than the image from which the position data is obtained, then additional information may be obtained. Ideally, therefore, the positional data is obtained from at least one imaging process, with which the real-time image is created, and at least an imaging method different from the real-time image imaging method. Thus, if the real-time image is generated by the ultrasound method, the position data should be generated from at least one ultrasound image and at least one x-ray image.

The lesion can be marked in the real-time image, for example by a colored highlight or a visible border, for example with dashed lines. Such a marking can be carried out manually; but can also be generated computer assisted. This allows the lesion to be observed even better during the biopsy. Preferably, the lesion is monitored during biopsy so that changes to the lesion are detected. This is advantageous, in particular with a marked lesion, since the attending physician can also perform a visual inspection himself. Surveillance of the lesion includes, for example, recalculating the position of changes in the tissue area to be examined, such as a breast. That is, if, for example, the

As tissue moves, changes in position of the lesion may result, which may then be monitored computer-aided. Thus, during breast movements or minimal changes in compression, the lesion can be tracked and, if necessary, its position in the biopsy interface readjusted and / or a warning message issued. This allows the position control data to be recalculated dynamically and to ensure that the biopsy is done in the right place in the tissue. Preferably, the position data becomes not only one

But from two different imaging methods. This improves the quality of the positional data so that the lesion can be more reliably detected in the real-time image. The images from which the position data are obtained can preferably also be displayed, so that the attending physician can view them. This can be done on a separate monitor, in a separate window in the same monitor, in which the real time, or even before displaying the real-time image. Switching between the displays is also possible. In particular, the method for generating the real-time image is an ultrasonic method. In this case, the method further comprises the steps of applying a gel to the area where the ultrasound device is applied and applying compression with a compressive agent to the tissue to be examined. The compression means is in particular a gauze or gauze or a plate. In an ultrasound procedure, the application of an ultrasound gel by the position data of the lesion can be targeted only to a small area of the tissue to be examined. This has the advantage that ultrasound gel does not have to be applied everywhere on the tissue to be examined and is present. The gauze can be designed so that, for example, the mesh width is greater than the needle diameter of the biopsy needle and / or that the threads are designed tear-resistant. This makes it possible to perform a biopsy through the gauze (namely through a mesh in the gauze)

Gas network) through. In particular, in combination with the application of the ultrasound gel to a small portion only, this embodiment is advantageous because no tissue residue of a needle can get caught on the gauze and possibly get into the tissue or the needle can not be blocked.

Another possibility is that the gauze is removed at least in the area where the needle is to penetrate into the tissue. For this purpose, by means of a relief device a relief compression can be applied to the tissue area to be examined, which relieves the gauze. This allows the gauze to be removed. For this purpose, the gauze is notched or cut open on one side and removed by hand or automatically to the other side, preferably in the direction of the patient side facing away. In particular, if the gauze is completely covered with ultrasound gel on the tissue soaked, the gauze can easily be peeled off, even under a relief device with which the relief compression can be built up. Basically, the breast is placed on a fixation plate and biased with a gauze that is latched or otherwise secured to the platen on either side of the tissue area. The unloading device, such as a compression plate, can manually or automatically build up the compression and preferably has recesses through which a biopsy needle can be passed. The area of tissue on which the puncture of the biopsy needle is to take place is preferably also cleaned of possible ultrasound residues. This effectively prevents a possible infection.

After localization of the lesion and / or after a monitoring start of the examination, a change in the display geometry is possible, for example to bring the imaging unit in an optimal position for monitoring the lesion, or to make room for the biopsy.

It is also possible to perform image registration procedures to correlate the acquired images to determine the positional data of the lesion when the images have been acquired with different image acquisition devices.

The invention further relates to a device for controlling and supporting a biopsy. Such a device has a computer unit which comprises means for reading position data of a lesion, imaging means for displaying and generating a real-time image of a tissue region to be examined, in particular a breast, display means for displaying the real-time image and possibly also the images for Generation of the position data display, wherein the recording geometry of the real-time image of the recording geometry of the image for the position data of the lesion should correspond. The device preferably has means for marking and, in particular, monitoring the lesion in the real-time image. Furthermore, the apparatus may additionally comprise display means for displaying various images from imaging processes simultaneously with the real-time image. As an imaging method, the device has, in particular, an ultrasound device with which the real-time image can be generated. In addition, an X-ray unit can also be provided with which an image can also be generated, in particular for the acquisition of position data of a lesion.

The device also includes means for biasing, i.e. compressing, a region of tissue. In particular, a gauze is provided for this, which can be latched or otherwise fastened on a clamping plate. In addition, a release compression means is provided which can relieve the gauze and the tissue area to be examined maintains its compressed shape. This prevents that even when removing the gauze, the shape of the tissue area to be examined changes too much and thus the finding of the lesion becomes more difficult.

The device may also include a puller for removing the gauze. This ensures that the gauze is also removed cleanly.

Finally, the device can also have a biopsy device, which can then automatically perform the removal of a tissue sample. Alternatively, the device is in data exchange with a biopsy device, wherein the

Biopsy device is driven by the method described above. The controller or method may be partially implemented in software.

It is within the scope of the invention that not all steps of the method necessarily have to be performed on one and the same computer instance, but they can also be executed on different computer instances. Also If appropriate, the sequence of the method steps can be varied.

In addition, it is possible that individual sections of the method described above in a salable unit and the remaining components in another salable unit - as a distributed system - can be performed. Brief description of the figures

In the following detailed description of the figures, non-limiting exemplary embodiments with their features and further advantages will be discussed with reference to the drawing. In this show:

Fig. 1 shows a flow chart showing the necessary steps of a method according to the invention; and

Fig. 2 shows a schematic view of a device with clamped tissue, fixation plate, gauze and relief device. Description of preferred embodiments

A device according to the invention for carrying out the method according to the invention comprises an imaging device 3 which is suitable for supplying a real-time image of a tissue region to be examined. In particular, this may be an ultrasound unit 3. Other imaging modalities are also possible, for example a magnetic resonance system or, if the radiation exposure is irrelevant, also an X-ray unit.

The device may also include or be in communication with a second imaging device (not shown) that is in addition to the first imaging device. 3 is present. With these images of the same recording geometry, and in particular in the same recording level can be generated and the position of a lesion can be calculated from these images. For this purpose, the device has a computing unit which is suitable for creating position data. The lesion can be marked manually on a display unit (not shown). This manually marked area can then be stored as a position, but it is also possible with the appropriate software to have the lesions recognized automatically (via appropriate software-based means).

The device further has a fixing plate 4, on which the tissue area 2 to be examined can be fixed. In particular serves a gauze 7, which can be attached to both sides of the fixing plate 4 and applies a compression on the tissue to be examined area. The advantage of using a gauze 7 as a compression means is the possibility to carry out an ultrasound examination. The gauze 7 is for example by a rail,

Push buttons or a clamping unit on the side of the fixing plate 4 releasably secured. Furthermore, the device also has a relief device 8, which itself can apply a compression to the tissue region 2, thereby making it possible to relieve the gauze 7. This relief device 8 may consist in particular of a pressure plate which is pressed onto the tissue region 2. Such a relief device 8 can be permanently present on the device, but can also be fastened or latched with screws only at the time of the examination, for example, of the plate holder 5 of the fixing plate 4. However, the relief device 8 must be movable manually or automatically at least in the direction of the tissue area 2. In order to apply the relief compression to the tissue area, the relief device 8 is then driven onto the tissue area, wherein the pressure generated must be sufficient to relieve the gauze 7. The device may further comprise or be in communication with a biopsy device 9, with which the biopsy is performed. The biopsy can be performed laterally past the gauze. However, a puncture of the gauze (which can be maintained over a large area constant pressure and thus a constant compression on the tissue area) or the removal of the gauze 7 and the puncture of the relief device 8. For this purpose, 8 recesses are provided in the middle of the relief device, the either already open (see the indicated by dashed lines recesses 11 in Fig. 2) or can be opened manually or automatically, for example with a movable cover plate (not shown).

The gauze 7 itself is preferably made of tear-resistant threads, so that piercing the gauze does not cause the gauze material to penetrate into the point of penetration of the gauze

Biopsy device 9, such as a needle, penetrates. Additionally or alternatively, the gauze 7 can also be designed with very coarse meshes, so that the individual meshes are larger than the diameter of the biopsy needle. If the ultrasound gel then only exists on the region on which the ultrasound unit 3 images and monitors the biopsy in real time, it is also prevented that ultrasound gel can penetrate into the tissue to be examined at the puncture point.

Alternatively, the gauze 7 can be pulled away under the compression plate. In particular, in this case, the discharge device 8 is provided. It is preferred that the complete gauze 7 is provided with ultrasound gel, so that when pulling out the gauze 7 under the relief device 8, the ultrasound gel can be used as a kind of lubricant so that the removal of the gauze 7 is so pleasant for a patient as possible. The removal of the gauze 7 can be done automatically, for example by placing a metal pin (not shown) on one side of the fabric fabric. Reichs 2 is provided within the compression space under the gauze 7, which runs parallel to the gauze 7. When the gauze 7 is now released on the other side (for example, by being unlatched or cut open), by moving the metal pin away from the tissue area 2, the gauze can be pulled out between the relief device 8 and the tissue area. But there are also a variety of other ways to accomplish the removal of the gauze 7, for example, manually or with a roller 6, on which the gauze can be rolled up after loosening.

The computer unit further comprises means for superimposing the images displayed on the display unit. For example, an image from which the position data are calculated can be overlaid with the real-time image in order to be able to localize the lesion in the real-time image as precisely as possible. Furthermore, the device also has means for marking the lesion in the real-time image by means of the read-in position data. It is also possible to manually mark the lesion in the real-time image, for example by means of a touch screen or by means of other conventional operating means for screens (mouse, keyboard, etc.).

With reference to FIG. 1, a method according to the invention will be described below by way of example. First, the positional data of the lesion are created in step Sil. For this purpose, the lesion is identified in an image of a first imaging method and the coordinates are stored. In addition, another imaging method can also be used, for example, both from an ultrasound image and from an x-ray image and / or a recording of the magnetic resonance tomography. Alternatively, the data can also be imported from already existing images or images (eg stored in a database). However, the creation of the position data preferably takes place on the basis of newly generated images of the imaging methods, since the lesion is then easier to identify in the real-time image explained below. Furthermore, the position data can in principle also be captured from images that are generated with different acquisition geometries, provided that additional conclusions on the lesion can result. The images for the position determination of the lesion and also for the finding of the lesion can be generated with the same device as the method steps described below. Thereafter, the position data is read in in step S12, and in step S13, a real-time image is generated by an imaging process. The real-time image is generated in the same recording geometry of at least one recorded image from which the position data of the lesion were created. Then, the biopsy device can be driven accordingly to be performed in a later step and controlled under the supervision of the real-time image (step S14). Usually, the images of the lesion are generated by different imaging methods and / or in different recording geometries. For example, in the case of an X-ray, the area of tissue to be examined, in particular the breast, is usually pretensioned on a plate, for example with a gauze or through a gauze

Printing plate. By contrast, an ultrasound examination usually involves placing the patient on her back and examining the breast with the ultrasound machine. The two chest compressions are therefore perpendicular to each other.

Preferably, as an imaging method for the real-time image, an ultrasound device is used for the production of the ultrasound real-time image, but preferably the acquisition geometry which is usually used for X-ray images. As a result, a lesion detected in x-ray images can be more reliably identified in the real-time image generated with an ultrasound unit 3. Figure 2 shows in a schematic way the units involved in the process. The tissue 2 to be examined, in particular the breast, is here fastened and compressed on the fixing plate 4 with a gauze 7. Before or after that, at least at the area where the ultrasound unit 3 abuts against the tissue 2 to produce the real-time image is provided with ultrasound gel. The ultrasound gel can also be distributed over the entire gauze 7, so that a later removal of the gauze 7 is made possible without problems.

The biopsy device can be controlled or operated by means of three possibilities:

First, you can pass the gauze 7, whereby the distance to the lesion is comparatively large and the biopsy is made more difficult. However, it is possible in principle to carry out such a removal on the gauze 7 with the real-time image. Second, the gauze 7 can remain in place and the biopsy is done through the gauze. Preferably, this is done when the ultrasound gel is present only on a small portion but not directly on the lesion. The gauze preferably has meshes that are larger than the needle diameter of the biopsy device and / or has at least tear-resistant threads so that the material of the gauze 7 can not penetrate into the tissue.

Third, the gauze 7 can also be removed. For this purpose, with a relief device 8, for example, moved with a compression plate on the gauze 7, and generates a pressure on the fabric 2, which corresponds to the gauze 7. Thus, the gauze 7 is almost completely relieved and can, as already mentioned above, be removed. Of course, the real-time image of the imaging device can also be generated by magnetic resonance tomography or X-ray, depending on whether the radiation is to be avoided on the tissue or not. Therefore, it is also possible to examine a lesion in vivo or ex vivo.

The lesion itself can be highlighted in color or otherwise marked in the display panel of the display, for example with a border. The computer unit of the device may also monitor the lesion before, during and after the biopsy, ie, computer-assisted control of the position of the lesion and warning of movement of the lesion due to tension changes in the tissue or other movements, for example because the patient is moving output a sound or a visual signal and at the same time or instead recalculate the position of the lesion and display in the real-time image, in particular also mark.

Finally, it should be noted that the description of the invention and the embodiments are not to be understood as limiting in terms of a particular physical realization of the invention. It is particularly obvious to a person skilled in the art that the invention can be implemented partially or completely in software and / or hardware and / or on a plurality of physical products - in particular also computer program products.

Claims

claims

1. Method for preparing and controlling a

Biopsy device comprising the steps:

- reading (S12) position data of a lesion from at least a first image of a first imaging method;

- Preparing the tissue area to be examined (2) with the lesion;

- Create a second shot as a real-time image

2013 (S13) with a second imaging method at least in the area of the lesion with a capture geometry that matches that of the first capture;

-Localize (S14) the lesion in the real-time image

Based on the read position data and generating position control data;

- Display the real-time image with the localized lesion

- controlling the biopsy device based on the generated

Position control data.

The method of claim 1, wherein the first and second imaging methods are performed on different modalities.

3. The method of claim 1 or 2, wherein the lesion is marked in the real-time image.

A method according to any one of the preceding claims, wherein the position of the lesion in the real-time image is monitored.

5. The method according to any one of the preceding claims, wherein the position data of the lesion are generated by means of the recording of the first imaging method.

6. The method of claim 5, further comprising the step of generating the first shot (Sil) for reading the position data.

A method according to any one of the preceding claims, wherein two or more images of coincidental or different imaging techniques are used to generate the positional data.

8. The method of claim 1, wherein the imaging method for generating the real-time image is an ultrasound method and the method further comprises the steps:

- applying a first compression to the tissue to be examined;

Applying ultrasound gel to at least the area of the lesion to which the ultrasound unit is applied.

9. The method of claim 8, further comprising the steps of generating the real time image:

- Applying a discharge compression on the tissue to be examined (2);

- Remove the applied first compression.

10. Apparatus for preparing and controlling a

Biopsy device (9), comprising:

- A computer unit with a read-in device for reading position data of a lesion;

- at least a first imaging unit (3) for generating a real-time image of a tissue to be examined (2) with a lesion; and - A control unit for detecting the lesion based on the position data in the real-time image and for controlling the biopsy device (9).

The device of claim 10, wherein the image analysis unit is further adapted to mark and / or monitor the lesion.

The apparatus of claim 10 or 11, further comprising another imaging unit different from the first imaging unit.

13. Device according to one of claims 10 to 12, wherein the first imaging unit is an ultrasound unit (3).

14. The device of claim 10, further comprising a biopsy unit.

15. Device according to one of the preceding device claims, further comprising:

- At least one display device for displaying the generated real-time image;