EP3073943A1

EP3073943A1 - Needle guide for biopsy

Info

Publication number: EP3073943A1
Application number: EP14833115.0A
Authority: EP
Inventors: Hubert Noras
Original assignee: Individual
Current assignee: Individual
Priority date: 2013-11-29
Filing date: 2014-11-14
Publication date: 2016-10-05
Also published as: DE112014005435A5; DE102013113277A1; WO2015078445A1

Abstract

Biopsy device comprising a needle guide (4, 4') for a biopsy needle (41, 41'), a frame (3, 3'), a first manipulator (11, 11') which is connected thereto and is freely displaceable relative to the frame (3, 3') along a first coordinate axis (12, 12') in and/or parallel to the translation plane (31, 31') spanned by the frame (3, 3') and/or the first and a second manipulator (11, 11'), (13, 13'), the second manipulator (13, 13') which is connected to the first manipulator (11, 11') and is freely displaceable relative to the first manipulator (11, 11') along a second coordinate axis (14, 14') linearly divergent from the first coordinate axis in and/or parallel to the translation plane (31, 31') spanned by the frame (3, 3') and/or the first and a second manipulator (11, 11'), (13, 13'), and a first hinge (21, 21') which is connected to the second manipulator (13, 13') and is freely pivotable relative to the second manipulator (13, 13') about a first pivot axis (22, 22') which extends in and/or parallel to this translation plane (31, 31') and is connected to the needle guide (4, 4').

Description

Needle guide for biopsy

The invention relates to a biopsy device and an associated method for the use thereof.

In medicine, especially in magnetic resonance imaging, needle guides are already being used to make biopsies.

A biopsy needle guide according to the prior art shows EP2347717B1, wherein the biopsy needle guide described therein can be pivoted in a plane. However, the pivoting is not reproducible by a scale or similar device. Much more disadvantageous, however, is that the entire device can not be moved in a predetermined manner in a translation plane.

Another alternative biopsy needle guide is in

US20120203095A1 discloses. Here a pivoting of the biopsy direction is possible. However, there is only one translational degree of freedom, namely a displacement along a rotatable axis, against which the biopsy needle can be pivoted further. This prior art lacks the ability to move the biopsy needle to any point of a translation plane without changing direction simultaneously.

The invention is therefore based on the object reproduzier displaceable and pivotally form a biopsy needle guide in a translation plane.

To solve the problem, the invention proposes a device with the features specified in claim 1. It is advantageous to provide in the biopsy device a frame in which a first manipulator is mounted. The frame can serve as a mounting frame of the biopsy device. The needle guide is connected to the first manipulator via other components. The first manipulator thereby indirectly moves the needle guide along a first coordinate. The first coordinate lies in a translation plane which lies in or parallel to the plane defined by the frame. Here and in the following, the translation plane may be replaced by planes that are parallel to the original translation plane, and coordinates may be replaced by corresponding parallel-shifted coordinates.

While the first frame-side manipulator part belonging to the first manipulator is connected to the frame, the first needle-side manipulator part likewise belonging to the first manipulator is connected to a second manipulator. The needle guide is connected to the second manipulator via at least one of the further components mentioned below. The second manipulator moves the needle guide along a second coordinate. The second coordinate is also in the translation level. First and second coordinates are chosen as not parallel. Preferably, they are optionally selected after parallel displacement in a common translation plane at least locally mutually perpendicular. This includes the use of translational as well as rotary manipulators.

Usually first and second manipulator are installed parallel to the frame. In this case, the translation plane is spanned by the frame as well as by the first and second manipulator. However, it may be necessary to tilt first and second manipulator with respect to the frame. In this case, the translation plane of the first and second manipulator is clamped.

A cross slide is an advantageous embodiment of the first and second manipulator. In the cross slide, the first and second coordinates are perpendicular to each other. First and second manipulator are translationally formed.

Connected to the second manipulator is a first joint. The first pivot axis corresponding to the first joint extends, possibly after parallel displacement, likewise in the translation plane. The needle guide is indirectly connected to the first pivot axis directly or via at least one of the other components mentioned below.

To save space, it is advantageous to form the second manipulator and the first joint together as a sliding bearing.

When the needle guide is directly connected to the first hinge, the needle guide is preferably attached, possibly after parallel displacement, with a direction perpendicular to the direction of the first pivot axis.

It is particularly advantageous, however, between the first

Pivot axis and the needle guide to provide a second joint which has a different direction from the first pivot axis direction. In this way, namely, the needle guide to two independent axes, namely the two pivot axes are pivoted. This, together with the translations of the first and second manipulators, provides maximum flexibility in biopsy. It is favorable to select the direction of the first pivot axis perpendicular to the direction of the second pivot axis.

Another embodiment is such that only the second manipulator is translational, the first but rotatory. For this purpose, the frame has a circular opening and forms a circular first frame-side manipulator part. Inserted into this, the first needle-side manipulator part can be rotated or rotated about a rotation axis of the first manipulator. The axis of rotation is chosen perpendicular to the translation plane. Attached to the first needle-side manipulator part is the second manipulator. Its second frame-side manipulator part has two parallel rails, on which slides a carriage as a second needle-side manipulator part. The second coordinate, along which the second needle-side manipulator part slides, extends radially relative to the axis of rotation, intersects the axis of rotation and is perpendicular to it. In this way, the position of the second needle-side manipulator part is designed to be displaceable as a function of the angle of rotation of the first manipulator and the position of the second manipulator in the manner of a polar coordinate system. With the exception of the special case that the second needle-side manipulator part assumes the position of the axis of rotation, the movement of the second needle-side manipulator part always runs perpendicular to the second coordinate upon rotation of the first manipulator, ie along the first coordinate. In accordance with the position of the first manipulator designed to be rotatable here, the first and second coordinates are rotated in this case. In this exemplary embodiment, it is furthermore advantageous to design the second coordinate and the first pivot axis in such a way that, at least after parallel displacement. tion of the second coordinate and the first pivot axis in the translation plane are perpendicular to each other.

Because then moves on rotation of the first manipulator, the axis of the biopsy needle on the mantle of a double cone. If the tip of the double cone at the site to be biopsied is selected by suitable adjustment of the second manipulator and the first joint, the path on which the biopsy needle arrives at the site to be biopsied can advantageously be achieved by mere rotation of the first manipulator Double cones can be chosen freely. Of course, the rotational symmetry axis and thus also the tip of the double cone lie on the axis of rotation of the first manipulator. In order to be able to freely choose the location to be biopsied despite this restriction, if necessary, the entire frame can be made displaceable by two further manipulators mounted outside.

Further details and features of the invention are explained below with reference to examples. However, these are not intended to limit the invention, but only to explain. It shows in a schematic representation:

Fig. 1 biopsy device with translational manipulators in general view in the middle position of the needle guide

Fig. 2 biopsy device with translational manipulators in general view in the shifted and pivoted position of the needle guide

Fig. 3 biopsy device with translational manipulators seen from above in the middle position of the needle guide

Fig. 4 biopsy device with translational manipulators seen from the side in the middle position of the needle guide Fig. 5 biopsy device with translational manipulators in section from the side seen in the middle position of the needle guide

6 Biopsy device with rotatory manipulator and translatory manipulator in overall view FIG. 8 Biopsy device with rotatory manipulator and translatory manipulator seen from above FIG. 9 Biopsy device with rotatory manipulator and translatory manipulator seen from the side FIG Biopsy device with rotary manipulator and translational manipulator seen in section from the side

1 shows a biopsy device with translationally designed manipulators seen from above in the central position of the needle guide 4. FIG. 2 shows the same biopsy device, but in the shifted and pivoted position of the needle guide 4. In FIG. 3 it is seen from above shown in the middle position of the needle guide 4, seen in Fig. 4 from the side in the middle position of the needle guide 4, in Fig. 5 in section from the side seen in the middle position of the needle guide. 4

He carries, locked by a first screw 301, a first frame-side manipulator part 1 1 1, which is connected via dovetail rails with a first needle-side manipulator part 1 12 The first manipulator 1 1 comprises the first frame-side manipulator part 1 first 1 and the first needle-side manipulator part 1 12. The first manipulator 1 1 can be locked by a second screw 302 and a third screw 303. The first needle-side manipulator part 1 12 is a carriage which is relatively to the first frame-side manipulator part 1 1 1 and frame 3 can be moved along a first coordinate 12. This shift can be read on a first scale 1 13, which can be attached to the first frame-side manipulator part 1 1 1.

The first screw 301 serves at the same time for a possible tilting of the first frame-side manipulator part 1 1 1 and all other components connected to the frame 3. This can be seen by comparing FIG. 1 without this tilting and FIG. 2 with this tilting , As a result of this tilting, the first coordinate 12 and the second coordinate 14 and the translation plane 31 embedding it are also tilted. The translation plane 31 may then not be parallel to the plane defined by the frame 3. This may be beneficial if the patient's surface is also not parallel to the plane defined by the frame 3.

The first needle-side manipulator part 1 12 also serves as a carrier for a second frame-side manipulator part 131. The second manipulator 13 comprises the second frame-side manipulator part 131 and the second needle-side manipulator part 132. The second frame-side manipulator part 131 has, transverse to the direction of the first coordinate 12, a first bushing 213 which receives the second needle-side manipulator part 132. The second needle-side manipulator part 132 has a second scale 133, at which the displacement of the second needle-side manipulator part 132 relative to the second frame-side manipulator part 131 can be read along the second coordinate 14.

The first bushing 213 simultaneously serves to realize the first joint 21. The second frame-side manipulator part 131 serves namely at the same time as a first frame-side joint part 21 1 and the second needle-side manipulator 132 also serves as a first needle-side joint portion 212. First frame-side joint part 21 1 and first needle-side joint part 212 are merged in the first socket 213. The first joint 21 comprises the first frame-side joint part 21 1, the first bush 213 and the first needle-side joint part 212. The first bushing 213 is designed as a plain bearing bush, for which reason the second manipulator 13 is simultaneously the first joint 21. Second manipulator 13 and first joint 21 together form a sliding bearing which has two mechanical degrees of freedom, one translational and one parallel rotational.

Coaxially with the first needle-side joint part 212 is the associated first pivot axis 22, about which the first needle-side joint part 212 can be pivoted. The first pivot axis 22 is parallel to the second coordinate 14 or is identical to it.

The second manipulator 13 can be locked by a fourth screw 304. The first hinge 21 can be locked by a fifth screw 305.

The first needle-side joint part 212 is connected to a perpendicularly projecting first angle indicator 214, the setting of which can be read on a first angle-side scale 215 provided on the first frame-side joint part 21 1.

The first needle-side joint part 212 also serves as a second frame-side joint part 231. This is associated with a second needle-side joint part 232. Second frame-side joint part 231 and second needle-side joint part 232 are brought together in a second sleeve 233. The second joint 23 comprises the second frame-side joint part 231, the second bushing 233 and the second needle-side joint part 232. The axis of the second joint 23 is the second pivot axis 24.

The second needle-side joint part 232 is connected to a second angle indicator 234 projecting perpendicularly therefrom, whose setting can be read on a second angle scale 235 provided on the second frame-side joint part 231 and / or on the second angle indicator 234.

The second hinge 23 can be locked by a sixth screw 306, which, as can be seen in FIG. 5, is located coaxially in the second frame-side hinge part 231 and can press on the second needle-side hinge part 232 via a guide pin 316.

For better locking of the second needle-side manipulator part 132 and at the same time the first needle-side joint part 212 on the second frame-side manipulator part 131 and at the same time the first frame-side joint part 21 1, a retaining plate 317 which can be locked by a seventh screw 307 is used.

Connected to the second needle-side joint part 232 is the needle guide 4 with the biopsy needle 41. The direction of the needle guide 4 and the biopsy needle 41 is selected perpendicular to the second pivot axis 24. The biopsy needle 41 is adjustable by the manipulators 1 1, 13 and joints 21, 23 in four degrees of mechanical freedom. Fifth and sixth degrees of mechanical freedom can be achieved by moving or rotating the biopsy sienadel 41 given in the needle guide 4, which forms a plain bearing yes. It is advantageous to make the needle guide 4 lockable by clamping the biopsy needle 41 so that the biopsy needle 41 can not penetrate into the patient in an uncontrolled manner. This can be done for example by a longitudinally slotted and provided with a conical external thread sleeve, which can be compressed by screwing a nut. Coaxial through sleeve and nut passes the biopsy needle 41, which is thereby clamped. Clamp the biopsy needle 41 from the side, such as through a

Screw, is also possible.

FIG. 6 shows a base plate 50 having first to eighth biopsy device openings 51 to 58. The fourth and sixth biopsy device openings 54 and 56 each incorporate one of the biopsy devices shown in FIGS. 1 to 5. For the sake of clarity, only the needle guide 4 and biopsy needle 41 are provided with identifiers by these biopsy devices. Other biopsy devices can also be incorporated into the base plate 50. The base plate 50 with inserted biopsy devices makes it possible to make biopsies at several and different locations. The incorporation of biopsy devices in the base plate 50 is possible in various ways, such as by locking bent resilient tabs, by clamping, by retaining clips or by screws.

FIG. 7 shows a biopsy device with rotary manipulator and translatory manipulator in an overall view. In Fig. 8, the same biopsy device is shown, but seen from above, seen in Fig. 9 from the side and in Fig. 10 seen in section from the side. In this biopsy device is the first manipulator 1 1 'designed to be rotatable and the second manipulator 13' translationally formed.

Basis of the biopsy device is the frame 3 'with, apart from rounded corners, square outer dimensions. These outer dimensions are suitable for base plates with base plates 50 with square biopsy device openings 51 to 58. Other, in particular circular outer dimensions of the frame 3 'are also possible.

Centrally, the frame 3 'has a large circular opening which simultaneously defines the translation plane 31' corresponding to a surface of the frame 3 '. In its center is perpendicular to the translation plane 31 'the axis of rotation 15'. The frame 3 'simultaneously forms the first frame-side manipulator part 1 1 1'. Used in these is the first needle-side manipulator part 1 12 '. First frame-side manipulator part 1 1 1 'and the first needle-side manipulator part 1 12' engage by a circular curved dovetail rail 1 14 'into one another. The dovetail profile can be seen in section in FIG. 10. The first manipulator 1 1 'comprises the first frame-side manipulator part 1 1 1' and the first needle-side manipulator part 1 12 '. The first manipulator 1 1 'can be locked by a second and third screw 302', 303 'or by other means. The first needle-side manipulator part 1 12 'is a carriage with a dovetail profile running on a circle, which can be rotated along the first, here circular, coordinate 12'. This rotational displacement can be read on a first scale 1 13 ', which is designed according to the rotational character of the first manipulator 1 1' as an angle scale. Connected to the first needle-side manipulator part 1 12 'via the second and third screw 302', 303 'is the second frame-side manipulator part 131'. The second manipulator 13 'comprises the second frame-side manipulator part 131' and the second needle-side manipulator part 132 '. According to the translational character of the second manipulator 13 ', the second frame-side manipulator part 131' has two parallel rails 131 1 ', 1312', on which the second needle-side manipulator part 132 'designed as a slide is displaced along the second, linearly and translationally formed coordinate 14' can be, which extends radially from the axis of rotation 15 '. The second frame-side manipulator part 131 'is axisymmetric in the translation plane 31' along the second coordinate 14 'and center line. In this way, thanks to the likewise axially symmetrical second needle-side manipulator part 132 ', it is possible to guide the needle guide 4' and thus the biopsy needle 41 'from the point where the rotation axis 15' intersects the translation plane 31 'in the radial direction and thus along the second Coordinate 14 'to move. The second needle-side manipulator part 132 'can be locked by a fourth screw 304' on the rails 131 1 ', 1312' of the second frame-side manipulator part 131 '. On the rails 131 1 ', 1312' there is a second scale 133 ', at which the displacement of the second needle-side manipulator part 132' relative to the second frame-side manipulator part 131 'along the second coordinate 14' can be read. The linearly formed second coordinate 14 'intersects, after displacements in the translation plane 31', the circularly formed first coordinate 12 'vertically.

In this way, as a function of the angle of rotation of the first manipulator 1 1 'and the position of the second manipulator 13' designed in the manner of a polar coordinate system, the position of the second needle-side manipulator 132 'slidably. With the exception of the special case that the second needle-side manipulator part 132 'occupies the position of the rotation axis 15', the movement of the second needle-side manipulator part 132 'always runs perpendicular to the second upon rotation of the first manipulator 11', ie along the first coordinate 12 ' Coordinate 14 '.

The second needle-side manipulator part 132 'has a first joint 21' parallel to the translation plane 31 'and perpendicular to the second coordinate 14'. In this case, the second needle-side manipulator part 132 'simultaneously forms the first frame-side joint part 21 1'. In the first joint 21 ', the first needle-side joint part 212' can be pivoted about the first pivot axis 22 'characterizing the first joint 21'. The first joint 21 'comprises the first frame-side joint part 21 1' and the first needle-side joint part 212 '. A first angle indicator 214 'is attached to the first needle-side joint part 212'. This can be used together with an attached to the first frame-side joint part 21 1 'angle scale 215', the pivoting of the needle guide 4 'and thus the biopsy needle 41' in the axis of rotation 15 'and second coordinate 14' plane against an axis of rotation 15 'parallel axis read off. The first joint 21 'can be locked with a fifth screw 305' which is coaxial with the first joint axis 22 '.

The second coordinate 14 ', the first pivot axis 22' and the axis of rotation 15 'are selected in an advantageous manner in pairs perpendicular to each other. Connected to the first needle-side joint part 212 'is the needle guide 4' with the biopsy needle 41 '. The direction of the needle guide 4 'and the biopsy needle 41' is selected perpendicular to the first pivot axis 22 '. The biopsy needle 41 'is adjustable by the manipulators 1 1', 13 'and the first joint 21' in three degrees of mechanical freedom. A fourth degree of mechanical freedom is not present in this biopsy device. Fifth and sixth degree of mechanical freedom is given by moving or rotating the biopsy needle 41 'in the needle guide 4', which forms a plain bearing. It is again advantageous to design the needle guide 4 'by clamping the biopsy needle 41' in a lockable manner.

In the lower region of the frame 3 'are four with respect to the axis of rotation 15' offset by 90 ° retaining clips 318 'is provided, each with a further screw 308' for clamping the frame 3 'and thus the biopsy device in a square biopsy Vornchtungsoffnungen 51 bis 58 on a base plate 50 are suitable.

The needle guide 4 'has five arranged in the form of the cube-eye five parallel holes, as in the above-mentioned perforated plates through which the biopsy needle 41' can optionally be stuck. Other bore arrangements, for example, 25 holes in 5 rows and 5 columns square, are possible.

The sectional drawing Fig. 10 shows in addition to many of the aforementioned components, a biopsy needle 41 ', which is received in a receiving device 42'. LIST OF REFERENCE NUMBERS

11, 11 ', 13, 13' manipulator

111, 11V, 131, 131 'frame-side manipulator part

112, 112 ', 132, 132' needle-side manipulator part

113, 113 ', 133, 133' scale

114 'circular curved dovetail rail

12, 12 ', 14, 14' coordinate

1311 ', 1312' rail

15 'rotation axis

21, 21 ', 23 joint

211, 211 ', 231 frame-side joint part

212, 212 ', 232 needle-side joint part

213, 233 socket

214, 214 ', 234 angle indicator

215, 215, 235 angle scale

22, 22 ', 24 pivot axis

3, 3 'frame

301-307, 302'-305 ', 308' screws

31, 31 'translation plane

316 guide pin

317 retaining plate

318 'retaining clips

4, 4 'needle guide

41, 41 'biopsy needle

42 'receiving device

50 base plate

51-58 biopsy device opening

Claims

Patent claims

1 . Biopsy device with a needle guide (4, 4') for a biopsy needle (41, 41'), a frame (3, 3'), a first manipulator 11, 11' connected thereto, which is relative to the frame (3, 3') along a first coordinate (12, 12') in and/or parallel to that through the frame (3, 3') and/or the first and a second manipulator (1 1, 1 1 '), (13, 13 ') spanned translation plane (31, 31 ') is freely displaceable, the second manipulator (13, 13') connected to the first manipulator (1 1, 1 1 '), which is relative to the first manipulator (1 1, 1 1 '). ) along a second coordinate (14, 14') which deviates linearly from the first and/or parallel to that through the frame (3, 3') and/or the first and a second manipulator (1 1, 1 1 '), (13, 13') spanned translation plane (31, 31') is freely displaceable, and a first joint (21, 21') connected to the second manipulator (12, 12'), which is relative to the second manipulator (13, 13' ) is freely pivotable about a first pivot axis (22, 22'), which runs in and/or parallel to this translation plane (31, 31') and is connected to the needle guide (4, 4').

2. Biopsy device according to claim 1, characterized in that at least after parallel displacement of the first coordinate (12, 12 ') and the second coordinate (14, 14') in the translation plane (31, 31 ') on the first coordinate (12, 12') vertical second coordinate (14, 14'). Biopsy device according to claim 1 or 2, characterized in that a translationally designed first manipulator (1 1), a translationally designed second manipulator (13), which is designed in the form of a sliding bearing at the same time as a first joint (21), the first

Pivot axis (22) has the direction of the first coordinate (12), and a second joint (23), which is provided between the first joint (21) and the needle guide (4) and relative to the first joint (21) about a second pivot axis (24), which deviates from the first pivot axis (22), can be pivoted freely.

Biopsy device according to claim 3, characterized in that a second pivot axis (24) perpendicular to the first pivot axis (22).

Biopsy device according to claim 1 or 2, characterized in that a rotationally trained first manipulator (1 1 '), the axis of rotation (15') of which is perpendicular to the translation plane (31'), and a translationally trained second manipulator (13'), the second Coordinate (14 ') has an intersection with the axis of rotation (15') of the first manipulator (1 1 ') and is perpendicular to it.

Biopsy device according to claim 5, characterized in that a first pivot axis (22') which is perpendicular to the second coordinate (14') at least after the second coordinate (14') and the first pivot axis (22') have been parallel shifted into the translation plane (31'). .

7. Method for using a biopsy device according to one of the preceding claims, characterized in that first the position of the tissue to be removed is localized, the optimal insertion angle for the biopsy needle is determined and the first (1 1) and second (12) manipulator and the pivot axis accordingly can be adjusted and the tissue is then removed by inserting the biopsy needle into the needle guide (4).

8. Biopsy method according to claim 7, characterized in that the second coordinate (14, 14') is aligned perpendicular to the first coordinate (12, 12').