DE10212154A1 - Handheld biopsy unit for the removal of tissue, comprises at least one tensioning and launching unit, and a needle unit with an outer hollow needle and a hollow biopsy needle - Google Patents

Abstract

A handheld biopsy device for the removal of tissue. A handheld biopsy device for the removal of tissue, comprises at least one first and second drive unit, at least one tensioning and launching unit in the form of a slide (28) for a biopsy needle unit. The launching unit has a spring acting on it, and the needle unit has an outer hollow needle (3) with a cutting blade (2) which is presharpened at the distal end, and a hollow biopsy needle. The latter is located in the outer hollow needle and has a space for removing tissue samples. A pressure source can be connected to the hollow biopsy needle, and the handle has a housing containing drive units and at least one cover (10). The pressure source is connected via a connection line inside the housing.

Description

The invention relates to a biopsy device, consisting of a handpiece, in the a hollow biopsy needle is inserted, part of which is over the handpiece protruding part of the biopsy needle with its sampling space into it Examining tissue is insertable and the tissue in the vacuum Sampling room sucked in and then using a Sample separation device is separated and then removed.

GB 2018601 A already discloses a method and a device for Cutting out tissue is known in which the tissue in under vacuum the biopsy needle is sucked into a cutting area. To be in the hollow needle The handpiece in which the hollow needle is integrated is used to create a vacuum Lines with a vacuum generator arranged outside the handpiece connected. The sample is cut off by a cutting device, which is located in the Hollow needle is arranged to be longitudinally movable. The separated sample is in the needle stored. After pulling the needle out of the tissue, the rinsed sample rinsed out of the needle tip; that's why Handpiece via further lines with devices outside the handpiece connected. The vacuum created in the hollow needle is transferred into the lines Integrated controls regulated.

A further biopsy device is known from EP 0890 339 A1 Vacuum influence the sample is taken. The handpiece in which the biopsy needle is is integrated with cutting device, is via hose connections and lines an external vacuum generator and control units. The vacuum will via a channel formed on the outer sleeve of the biopsy needle to the Sample room introduced from below. The separator is in the cavity the biopsy needle is longitudinally displaceable. By a rotating movement, combined with a manual longitudinal thrust, the cutting device cuts the Sample from the tissue. The sample is in the hollow channel of the separator transported. A similar arrangement is also shown in US Pat. No. 5,526,822.

In the known biopsy devices that take a sample under vacuum allow, the handpiece of the biopsy device is over at least one Connection hose and / or supply cable with one or more external Freedom of movement for supply units; are beyond the facilities for generating vacuum consuming, especially with regard of the control devices. The sample is held in the needle cavity by rotating separators cut out.

The object of the invention is to increase the mobility of the handpiece improve. Furthermore, the vacuum generating device should be simple, reliable and easy to set up and work. Sampling should take place in such a way that the pathologist has an untwisted sample for assessment.

The achievement of this object is achieved in that the Vacuum generating device used to generate a positive pressure if necessary is and the vacuum generating device and other control and Utilities are integrated in the housing of the handpiece and that Connection element from the biopsy needle to the vacuum / pressure generating device are arranged directly on the housing and thus the freedom of movement of the Handpiece not through lines leading to external supply devices or cable is obstructed.

To make the vacuum generating device particularly simple and reliable design, the use has been made to create the vacuum and the excess pressure a piston / cylinder unit with ventilation option. Particularly advantageous is the use of a known syringe / piston unit, with an additional Ventilation hole arranged in the upper part of the syringe body for dismantling the vacuum is opened by pulling back the syringe plunger. By Control of the spindle drive of the piston spindle can be the same piston / Syringe unit, depending on the requirement, from creating a vacuum to the Generation of an overpressure can be reversed, thereby reducing the vacuum a hole arranged in the upper part serves, through which air flows in is subsequently compressed.

To the movement of the piston, especially with regard to the reversal from Building a vacuum, breaking down a vacuum and creating an overpressure To be able to control, the drive is a spindle drive with electrical DC motor with a downstream reduction gear proved to be advantageous, because the measured number of revolutions of the engine is directly a measure of the Represents longitudinal displacement of the piston. Since it is a DC motor with high speed is acting, its output speed via a reduction gear the longitudinal movement of the spindle can be precisely controlled. about corresponding setpoint values in the control electronics, for. B. the number of revolutions of the motor, the length of the spindle path and thus the size of the vacuum and the overpressure can be specified.

Since a sterile biopsy needle is used in every patient, one has become Separation of sterile parts and other, only disinfected parts that are fixed connected to the handpiece, proven to be advantageous. That's why it is cheap, the vacuum / pressure generating device, the biopsy needle with cutting sleeve and the parts connected to the biopsy needle and cutting sleeve, such as biopsy needle carriers, Drive elements and plastic part including connecting element and Leadership role as an independent, easily insertable and removable sterile Insert element to train. The space for the insert element is for the sake of Cleaning separated from the other drive elements by covers.

For the sake of simplicity, the flexible connecting element is called a flexible hose trained so that it adapts to the displacement paths of the tension slide can. To twist the tubing opposite the biopsy needle at the proximal end is an additional, rotatably mounted plastic part that is firmly attached to the biopsy needle connected plastic part to which the hose is attached.

In order to keep the number of drives low, the same drive is used for the Clamping device and the longitudinal movement of the cutting sleeve used and is like that Drive of the vacuum / pressure generating device as a spindle drive from one DC motor is driven with a downstream reduction gear, educated.

To the longitudinally connected to the gear connected to the spindle sleeve enable z. B. when triggering the tensioning carriage, is a toothed roller as a drive intended.

In order to tension the tension slide by twisting the To bring the cutting sleeve, the front gear on the Threaded spindle sleeve supported on a holder of the base block, so that the Biopsy needle carrier is moved to the right while the cutting sleeve is in position maintains.

The clamping carriage has a double-armed lever, one of which is locked Arm engages in the recess of the tension slide under spring pressure. To the Tensioning device for different biopsy needles with different insertion depths, z. B. to use 15-25 mm, it requires z. B. just an adjustment the locking lever length and a corresponding specification in the electronics

The plastic part attached to the biopsy needle enables a knurled wheel a twisting of the sampling space. By the interaction of the polygon of the plastic part with the biopsy needle holder, the biopsy needle is in the desired one Lockable position. A notch on the knurled disc shows this Operator in which radial position the opening of the sampling space is located.

The cross-section of the hollow biopsy needle is towards the sampling space by a Constriction, a stopper or a lip limited. This restriction is approx. 60-75% of the height and covers the upper, open part of the sampling space from above from here. This narrowing in front of the sampling space causes the vacuum from the Floor - when opening the sampling room - (i.e. when moving back the Cutting sleeve) sucks in the tissue to be examined. The narrowing prevents in addition tissue penetration into the rear part of the needle cavity. At the Ejection of the sample causes the pressure in the constriction to increase Sampling room, which has the cleaning effect especially in the sampling room improved. By applying the vacuum, the tissue of the sample is in the Sucked into the interior of the sampling space and adheres to the Interior wall. For better adhesion you can use the interior of the sampling room additional funds may be provided. Because the cutting sleeve on the outside diameter the biopsy needle is arranged and thus the separation of the tissue on the outside takes place, the tissue adhering to the interior is due to the outside arrangement the cutting sleeve is not detached from the inner wall by the cutting device. In addition, the tissue cannot rotate in the cavity Penetrate the cutter and adhere to it. The leadership of the cross-section laps The cutting sleeve on the outside of the cross-sectional biopsy needle has through this Arrangement the advantage that no twisting (twisting) of the sample by the Cutting rotation of the cutting device takes place and thus an essential Prerequisite for the assessment of the tissue by the pathologist is met. Around to get a good adhesion of the sample in the interior without increasing the degree of filling impairment, the sampling room is designed so that approx. 25% of the Cross-section of the sampling space is open for the aspiration of the sample, d. H. the most of the perimeter is closed.

The outside arrangement of the coaxial cutting sleeve also causes a larger sample can be taken than with the inside arrangement of the Cutting sleeve.

No one finds that the sample is ejected with pressure from the sampling chamber Tissue damage instead.

Due to the central arrangement of the base block in the center of the interior of the housing the housing itself is exposed to transverse forces caused by the drive elements, relieved. In addition, the exchange of drives, as well as the Clamping carriage easy to carry out, since only the connections to the housing are required for this have to be solved. It is also advantageous that the through the plastic slide generated shocks are absorbed by the base block.

The storage of the biopsy needle / cutting sleeve in a biopsy needle carrier Plastic has u. a. the advantage that a through the molded sliding surfaces trouble-free sliding on the counter surfaces of the base block and the molded Blocks is made possible. The biopsy needle carrier transfers the forces from the spindle drive the cutting sleeve on the clamping slide. Since the spindle drive at Adjustment of the tensioning slide is supported on the base block bracket and at Rotation of the clamping sleeve can slide freely (the gear can axially in the toothed roller slide), the drive can be used for both movements (tensioning the Tension slide, opening and closing of the sampling space using the Cutting sleeve) can be used. The microswitch integrated in the housing end part, the by closing the housing cover when the vacuum / Pressure generating device switches the power supply off, or on and on as the on Safety wings attached to the biopsy needle carrier are safety devices which prevent tensioning of the tension slide when the housing cover is open he follows. In addition, the case cover should be opened with the needle under tension turned off.

All supply units are housed in one housing and control the Drives are carried out electronically. In addition, partial steps of operation summarized and run automatically. By arranging the operating and Monitoring elements on a circuit board, which is arranged on the front, leaves the device can be operated with one hand.

The one stored in the housing end cover and by the biopsy needle with cutting sleeve Penetrated guide role works with the cannula previously placed in the tissue together. As on the proximal end of the previously placed coaxial cannula Sealing element is placed that interacts with the cutting sleeve prevents air from entering between the cannula and the cutting sleeve. The on the Cannula attached guide roller prevents contamination of the Inner housing takes place and that the non-sterile handpiece is the coaxial cannula touched. Thanks to the circuit board on the handpiece with integrated LEDs and switches and pictograms, simple operator guidance is achieved.

The cover plate can also be used as a support for microswitches or photocells become.

The insertion aid makes it easier to insert the sterilized Exchange element.

An exemplary embodiment is described in more detail below with reference to drawings. It shows:

Fig. 1 biopsy device with the housing cover open (in perspective);

Fig. 2 is fixed to the housing unit of the biopsy device (without the housing base and lid) and replaceable biopsy unit; shown (in perspective) separately;

Fig. 3 shows a longitudinal section AA through the biopsy needle in Fig. 1;

Fig. 4 cross section BB in Fig. 1 (left housing part);

Fig. 5 cross section CC in Fig. 1 (right housing part);

Fig. 6 right housing end cover (inside) with integrated microswitch;

Fig. 7 front of the board;

FIG. 8a base block in the X-axis viewed from the front (in perspective);

Fig. 8b base block in the X-axis seen from the rear (perspective);

FIG. 9a is fixed to the housing unit of the biopsy device without a housing cover and bottom in the untensioned state;

FIG. 9b latching device in the untensioned state;

Fig. 10a As Fig. 9, but clamping slide in the cocked position;

Fig. 10b As Fig. 9a, but in the locked state;

FIG. 11a biopsy needle tip side view;

. Fig. 11b is a longitudinal section through Figure 11 (sampling space opened);

FIG. 11c As in FIG. 11b, however (sampling space half open);

. 11b (closed sampling space by means of cutting sleeve) Figure 11d As shown in FIG.

Fig. 11e section AA in Fig. 11a;

Fig. 12 Biopsy needle holder with pressed-in biopsy needle / cutting sleeve and plastic part (from below, rotated by approx. 90 °, in perspective);

Fig. 13 vacuum / pressure device, installation and drive (seen from behind, in perspective);

FIG. 14a vacuum / pressure device placed on the syringe bottom flask (starting position for vacuum generation and end position for pressure generation, partially cut away);

Fig. 14b vacuum / pressure device with the piston retracted; End position of the vacuum stroke (partially cut open);

Fig. 14c releasing the ventilation hole; (Syringe plunger retracted via ventilation hole; pressure compensation position, partially cut open);

Fig. 14d section AA through the threaded spindle in Figure 14c.

Fig. 15 base block and biopsy needle / cutting sleeve prepared for assembly with photo cells and micro-switch for the actual value acquisition;

Fig. 16 insertion element lifted off from the insertion aid (in perspective);

Fig. 17 insertion aid (perspective).

Old devices necessary for carrying out a vacuum biopsy are integrated in the housing interior of a handpiece 1 ( FIG. 1), so that no cables or lines from the housing of the handpiece to further external supply devices are required. The handpiece 1 thus represents a complete vacuum biopsy device which is freely movable in all directions. The distal part of the hollow biopsy needle 2 with the cutting sleeve 3 coaxially surrounding it protrudes from the distal part of the housing end cover 6 and is required for taking the tissue sample. Usually a coaxial cannula is inserted into the tissue into which the biopsy needle 2 with cutting sleeve 3 is inserted. Outside the right housing end cover 7 , a connecting element 4 is guided, for. B. a transparent, flexible tube that connects the vacuum / pressure generating device 5 arranged parallel to the biopsy needle to the inner cavity of the biopsy needle 2 . The hollow connecting element 4 is arranged in the immediate vicinity of the housing end cover 7 . The biopsy needle with cutting sleeve and further elements arranged in a biopsy needle carrier 37 forms with the connecting element 4 and the vacuum / pressure generating device 5 an element 20 which can be easily removed and inserted and which is exchanged as required ( FIG. 2). For this purpose, the housing cover 10 is opened. As shown in FIG. 2 in particular, the biopsy device can be divided into parts which are firmly connected to the housing (disinfected parts) and into a removable element 20 (sterile part)). While the parts firmly connected to the housing are merely disinfected, the removable element 20 is delivered sterile packed and renewed as required, especially for each new patient.

In the exemplary embodiment described below, the vacuum / Pressure generating device arranged parallel to the biopsy needle. As part of the However, the vacuum / pressure generating device can also be in the axis of the invention Biopsy needle or the handpiece to be arranged horizontally; neither is needed own connecting element if they z. B. immediately to the end of Biopsy needle is attached.

Between the left and right housing end covers 6 , 7 there is a lower housing part 9 and a housing cover 10 with a locking latch 11 which is pivotably mounted in the housing end covers. Tie rods or screws that are partially screwed into a base block 8, the lower housing part is clamped between the Gehäuseenddeckel 9 6, 7, or connected to the base block. 8 The housing cover 10 is pivotally connected via an axis fastened in the housing end covers 6 , 7 . The housing cover 10 is closed before the biopsy device is operated; the inner contour of the housing cover corresponds to the outer contour of the biopsy needle carrier 37 described in more detail later. Approximately in the center of the housing interior, the base block 8 is arranged, which, for. B. is firmly connected via fixing elements and / or via a screw connection. With the base block 8 , which extends not only in the longitudinal axis from the center to the left, but also over the entire transverse surface, the drive elements for the vacuum / pressure generating device 5 , the cutting sleeve 3 and the clamping device for the clamping slide 28 , on the the biopsy needle carrier 37 is attached, connected. Furthermore, the base block 8 has a holder 36 which is open at the top for the biopsy needle / cutting sleeve and a further insertion element 62 for the vacuum / pressure generating device.

To describe the position of the individual elements and the position of the individual parts, in particular in the interior of the housing, a coordinate cross was drawn in FIG. 1, the coordinate center of the coordinate system being in the center of the base block 8 ( FIG. 1). Thereafter, for the following description and for the claims for the directions given in the direction of the X axis, seen as left (distal) and opposite to the X axis, seen as right (proximal). For the other coordinates, in the direction of the Y-axis is considered to be above, opposed to the Y-axis as below and in the direction of the Z-axis as rear and opposite to the Z-axis as front ( FIG. 1). The coordinate system divides the interior space and the other references into left and right, in front and back as well as above and below.

Referring to these definitions are located approximately in the lower, front, left housing portion of the housing chamber, the common drive means 106 for the clamping device and the cutting sleeve and in the bottom, rear, left housing part, the drive means 105 (Fig. 13) for the vacuum / pressure generating means 5 , In the lower right part, the energy supply for the drive motors and other electrical equipment is housed, such as. B. for the control and / or monitoring elements; preferably batteries or a battery 111 , z. B. a 7.2 V lithium-ion battery, 1 Ah used. The front, right, upper housing interior lying above the battery compartment is largely used for the tensioning slide 28 with locking part ( FIG. 5); which is connected to a block 26 , which is part of the base block 8 . The battery compartment is sealed at the top by a partition plate 114 .

In the uppermost, front part of the housing interior is a biopsy needle carrier 37 which can be inserted and removed into the U-shaped, upwardly open insertion holder 36 of the base block 8 and into the upwardly pointing tab 40 arranged on both sides of the tensioning slide 28 , in which the biopsy needle / cutting sleeve unit is included Drive parts is rotatably mounted, which extends over almost the entire length of the handpiece. As described later, the biopsy needle carrier is longitudinally displaceable by means of the tension slide. This means that in the non-tensioned state, the left end face of the biopsy needle carrier 37 bears on the left housing end cover 6 , and in the tensioned state, the right end face on the right housing end cover 7 . "Almost the entire length" means that the biopsy needle carrier is at least shorter by the amount than the interior of the housing is required for the clamping process. Is the span of the tension slide z. B. 20 mm, the biopsy needle holder must be able to be moved by this amount. In general, the span is between 15 and 25 mm, depending on the biopsy needle used. It is therefore advisable to design the interior for the greatest possible span.

The clamping device (on the right, lying at the front) itself consists of a clamping slide 28 guided on a bolt 30 , the bolt being able to be screwed into the base block 8 . The bolt 30 is surrounded by a spiral spring 31 . The locking device (see in particular FIGS . 9b and 10b) of the tensioning slide is fastened to the block 26 . The vacuum / pressure generating device 5 with parts of the drive is accommodated in the upper, rear, right interior of the housing; the drive motor with reduction gear for the vacuum / pressure generating device is located in the left, lower, rear area of the interior of the housing.

The handpiece and in particular the biopsy needle or the vacuum / Pressure generating device are neither with cables or hose lines additional supply units located outside the housing handpiece connected. The mobility and maneuverability is therefore neither Lines still restricted by cables.

The housing cover, the lower housing part, the housing end cover and the Base blocks are preferably made of aluminum.

As already described, the handpiece 1 consists of a housing which is formed from a housing lower part 9 with laterally differently raised walls, the housing cover 10 adapted to the housing lower part with a longitudinally displaceable locking bolt 11 and the two housing end covers 6 , and 7. The lower part of the housing is connected to the two end caps via tie rods or screws, e.g. B. made of iron, which are partially screwed directly into the base block 8 . The housing is approx. 200 mm long, the housing end covers have an approximately square cross-section, approx. 40 × 40 mm, ( Fig. 2). The housing cover 10 can be pivoted about an axis 104 which is fastened in the housing end covers 6 , 7 ; the holes 14 in the housing end covers serve this purpose. The nose 12 of the locking bar 11 can be inserted into the recess 45 of the base block 8 to close the housing cover. The left housing end cover 6 has in the upper, front part an upwardly open U-shaped passage 13 for the part of the biopsy needle / cutting sleeve 2 , 3 projecting forward and the guide roller 81 arranged thereon. The rear housing end cover 7 has two U-shaped bushings 15 , 16 which are open at the top. The implementation 15 corresponds to the implementation 13 ; it receives the end of the cross-sectional plastic part 47 placed on the hollow biopsy needle. A nozzle 63 of the vacuum / pressure generating device is inserted into the feedthrough 16 ( FIG. 2). A further plastic part 112 inserted into the plastic part 47 has a pin 17 , which is used to connect the connecting element 4 to the outlet connection 64 of the vacuum / pressure generating device. The inner cavity of the biopsy needle is continuously connected to the cavity of the piston / cylinder arrangement and the cavity of the vacuum / pressure generating device via the likewise hollow connecting element 4 . The connections are designed in such a way that air cannot enter the system from the outside, and air cannot escape to the outside in the event of overpressure; the connection points are therefore airtight. As shown in FIG. 6 in particular, a microswitch 18 is integrated in the passage ( 16 ) of the housing end cover 7 on the lower side, the switching pin 19 of which protrudes into the passage.

As soon as the connector 63 of the vacuum / pressure generating device is inserted into the bushing and the housing cover is closed, the switching pin 19 of the microswitch 18 is pressed down and the microswitch 18 releases the power supply. The connections for connecting a charger can be installed in the bushings 97 , 98 of the housing end cover.

On the front side of the lower housing part 9 , a surface 113 is provided for the circuit board to be integrated with the operating and monitoring elements ( FIG. 1). The circuit board 57 to be fastened to the housing is designed as a separate component which is glued onto the surface 113 of the lower housing part 9 , for example. This circuit board 57 is connected via lines to further electronic components which are arranged in the housing and to the power supply. The circuit board mainly contains switches for operation and diodes for control. The actuation button 88 for the mechanical triggering of the tensioned slide carriage protrudes from a recess 65 in the lower housing part and the circuit board;

When designing the operating and monitoring elements, care was taken to differentiate between the tensioning process of the tensioning slide and the triggering of the tensioning slide on the one hand, and on the other hand performing the biopsy, such as removing the sample, and taking the sample with ejecting the sample. Accordingly, the actuation button 88 (trigger) for the tensioning slide has been set to the right and the tensioning button 90 which has triggered the tensioning of the tensioning slide has been set to the left. The program button 89 provided for performing the biopsy is in the center. Pressing the program button is required for three functions. The first function, beginning or repetition (reset) indicates the reset diode 91 , the sampling diode 92 arranged underneath indicates the opening and closing of the sampling space during the sampling. The lowest ejection diode 93 indicates the ejection of the sample taken. The tension diode 94 indicates the tensioning of the tension slide; the locking diode 95 indicates the locking of the tension slide. The battery charging diode 96 indicates the state of charge of the battery or the rechargeable batteries. The diodes are switched in such a way that the diode flashes when the called-up process is carried out and the diode of the subsequent process lights up after the process has been completed. If two options are available, both subsequent diodes light up. The operator is then free to choose which one to make. The mode of operation and control options are described in more detail in the description of the process. Symbols (pictograms) on the board symbolize the individual processes.

A perspective view of the base block 8 (viewed from the front in the direction of the X axis) is shown in FIG. 8a; the base block 8 from the back in the X-axis, Fig. 8B (both representations in perspective). The base block 8 can be divided into two halves in the longitudinal direction; the front part is used to fasten the common drive for the cutting sleeve and tensioning slide and in its upper part to support the biopsy needle carrier ( FIG. 8a); the rear part is used to fasten the drive for the vacuum / pressure generating device and to support one side of the vacuum / pressure generating device ( FIG. 8b). A central electronic circuit board is arranged between the two drive motors 21 , 58 , under the central rib 87 . The base block 8 has in its left, front part a U-shaped space 24 , in which a toothed roller 23 , which is driven by the geared motor 21 , is installed. For this purpose, the output shaft of the geared motor is mounted or inserted in an opening in the wall 25 of the base block 8 . The toothed roller 23 is attached to the output shaft and z. B. rotatably and securely fixed by means of a screw. On the other hand, the toothed roller 23 is mounted in the wall 22 of the base block 8 . A DC motor with a speed of approx. 11000 rpm is used as the drive motor. The DC motor is followed by a planetary gear with high reduction, on the output shaft of which the toothed roller 23 is placed.

A further block 26 is formed on the wall 22 pointing to the right, which not only holds the pivotable double lever 33 for locking purposes but also serves to fasten the bolt 30 for guiding the tensioning slide 28 . The bolt 30 is screwed into the threaded bore 29 . The clamping slide 28 slides to the right during the clamping process on the bolt 30 and the partition plate 114 arranged underneath. During the tensioning process, the spiral spring 31 arranged on the threaded bolt 30 is compressed. One end of the spiral spring is supported on an end piece 32 of the threaded bolt or directly on the housing end cover 7 ; the other end of the coil spring is supported on the end of the guide bore 115 of the tensioning slide.

The clamping slide 28 slides on the threaded bolt and the separating plate 114 and is thus secured against rotation. An arm 99 of the double-armed lever 33 of the latching device engages in a groove 27 of the tensioning slide 28 ( FIGS. 9a and 10a). The latching device integrated in the block 26 of the base block 8 consists of the double-armed lever 33 , which can be pivoted about a vertical axis 35 (seen in the Y axis) by means of a compression spring 34 . The axis 35 , a vertical pin, is fixed in the holes 38 of the base block. In the untensioned state, part 99 of the double-armed lever lies in the groove 27 of the tensioning slide; the compressed spring 34 acts on the part 100 of the lever in order to press the latching button 88 outwards (forwards). As soon as the part 99 of the double-armed lever can snap into the recess 82 of the tensioning slide, the actuation button 88 is pressed outwards. The tensioning slide is locked in the tensioned state by latching the lever part 99 and can now be triggered if required using the actuation button 88 . Since the tensioning slide is expediently made of plastic, it has proven expedient to insert a metal part 83 into the depression in order not to damage the plastic, since the double-armed lever is made of metal. In contrast to the removable element 20 , the handpiece with a renewed insert element is used several times. The span corresponds to the depth of penetration of the biopsy needle into the tissue. It follows that the length of the lever 99 also corresponds to the span. Since the penetration depths are generally between 15 and 25 mm, the same handpiece can be used for different penetration depths by appropriately designing the length of the lever 99 and changing the specification in the control.

The clamping slide 28 adjoining the block 26 is arranged at the same height and is approximately of the same cross section. The tension slide has two tabs 40 on its upper side. The upward-facing surface 41 of the tensioning slide, as well as the upward-facing surface 44 of the block 26 and the upward-facing surface of the extension 42 of the base block 8 , together form a flat bearing surface for the lower sliding surface 43 of the biopsy needle carrier 37 to be attached. The biopsy needle holder is made of plastic. When the tensioning slide is shifted from the untensioned initial state ( FIG. 9a) to the tensioned state ( FIG. 10a), that is to the right, the biopsy needle carrier 37 held by the tabs 40 slides over the surface 42 and 44 . It is also conceivable that the sliding surfaces are not flat, as in the exemplary embodiment, but have specially designed sliding surfaces; It is important that the biopsy needle carrier 37 can slide smoothly and in a straight line on the sliding surface and that after the actuation button 88 has been triggered, the biopsy needle can penetrate the tissue, the tumor, in a straight line. For this reason, the upper outer contour of the biopsy needle carrier is designed to match the inner contour of the housing cover and has only a slight play with the housing cover in order to prevent the biopsy needle from escaping upwards.

Above the U-shaped space 24 for the toothed roller 23 , at the height of the sliding surface 42 , the base block 8 has a U-shaped holder 36 , which is open at the top, for inserting the biopsy needle / cutting sleeve, among other things. This holder serves above all as a radial thrust bearing, that is to say for the support for the drive part connected to the cutting sleeve, the gear 74 , or the plastic disk 78, in order to bring the clamping slide into its clamping position by means of the drive device 106 , as will be described later.

In the rear, upper part of the base block, a further U-shaped insertion element 62 is provided, into which the free end 61 of the threaded spindle of the vacuum / pressure generating device protruding from the syringe body is inserted. In the middle, above, of the base block, there is a fastening for a plate which receives the recess 45 , into which the lug 12 of the locking bar 11 of the housing cover is inserted. A cover 46 , which is arranged on the base block 8 and points to the left, separates the space of the drive motors and the inserted circuit board from the upper, left part of the housing interior, which is used above all for the storage of the exchangeable biopsy needle carrier 37 , including the biopsy needle and cutting sleeve. The cover 46 protects the electric geared motors and the circuit board from contamination. The circuit board for the electronics is located between the drive motors and below the center rib.

FIG. 2 shows the biopsy needle carrier 37 , which can be inserted into the tabs 40 of the tensioning slide 28 with biopsy needle 2 and cutting sleeve 3 and further parts . The hollow, circular biopsy needle 2 has a needle tip 70 , to which the sampling space 71 is connected ( FIG. 11a-11e). The cross-sectionally round biopsy needle 2 is surrounded by a coaxially arranged, cross-sectionally round cutting sleeve 3 , which has a cutting edge 72 on its left end facing the sampling chamber, which is used after inserting the biopsy needle (with the sampling chamber closed) and after opening the sampling chamber and sucking it in Sample into the sampling room to cut out the tissue sample. The cutting edge is preferably perpendicular to the longitudinal axis of the biopsy needle and cutting sleeve. The cutting process takes place by rotation and simultaneous longitudinal displacement of the cutting sleeve by means of the threaded spindle drive. It is also conceivable that the movement is not continuous, but step by step or vibrating, ie the feed is moved back and forth at short intervals.

On the other, proximal end of the cutting sleeve facing away from the cutting edge 72 , a threaded spindle sleeve 73 is fastened with a gearwheel 74 arranged on the end face of the threaded spindle sleeve. The threaded spindle sleeve with gear is arranged on the cutting sleeve so that it cannot rotate and move. A threaded nut 75 works together with the threaded spindle and is firmly pressed into the biopsy needle carrier 37 . The gear 74 is on the left, ie before the start of the spindle sleeve. When the threaded spindle sleeve is rotated by means of the toothed wheel 74 , the cutting sleeve is rotated and displaced in the longitudinal direction over the biopsy needle 2 .

The gear 74 at the left end of the threaded spindle meshes with the toothed roller 23 after the insertion of the biopsy needle carrier into the tabs 40 . In order to be able to insert the biopsy needle carrier 37 into the tabs of the tensioning slide when the tensioning slide is not tensioned ( FIG. 2), the biopsy needle carrier has two flat, parallel recesses 77 . When the sliding surface of the biopsy needle carrier 37 is placed on the surfaces 41 , 42 and 44 , the cutting sleeve is simultaneously inserted into the holder 36 of the base block 8 . A plastic disk 78 , which is provided with a slight cone, can be inserted on the left side of the gearwheel to improve the rotatability of the spindle drive, in particular if the holder 36 serves as a support for tensioning the tensioning slide. When the biopsy needle carrier is correctly inserted, the biopsy needle carrier with the sliding surface 43 slides to the right over the surfaces 42 and 41 when the tensioning slide is tensioned. Since the sampling space is initially closed after the biopsy needle carrier has been inserted, the toothed wheel 74 rests on the holder 36 . If the toothed roller 23 is now driven further in the same direction, the threaded spindle drive screws the tensioning slide to the right via the biopsy needle carrier until it is locked; the biopsy needle is pulled inwards while the cutting sleeve remains in position. After locking, the cutting sleeve protrudes beyond the biopsy needle tip. Therefore, after the tensioning slide has been locked, the cutting sleeve is turned back into the starting position (opposite direction of rotation); the gear 74 is shifted from left to right in the toothed roller. After unlocking the tensioning slide, the biopsy needle / cutting sleeve with gearwheel slides back to the left with the biopsy needle carrier. Now the cutting sleeve can be moved to the right again to open the sampling space.

The right end of the cutting sleeve is connected to the hollow biopsy needle by means of a sealing element 76 so that it can rotate, but in an air-sealing manner, so that neither air can penetrate between the biopsy needle and the cutting sleeve surrounding it coaxially, nor can air escape under excess pressure. On the right end of the biopsy needle 2 , a round, also hollow plastic part 47 is placed in an airtight manner and non-positively connected to the biopsy needle. The plastic part 47 has at its left end a bearing element 49 which is pressed into the biopsy needle carrier; At its right end protruding from the handpiece, a further plastic part 112 is inserted, which can be rotated relative to the plastic part 47 and relative to the biopsy needle 2 . An O-ring for sealing is inserted between the biopsy needle and the plastic part 112 . The plastic part has a pin 17 on its right end, onto which the connecting element 4 is pushed in an airtight manner. Also on the right part, protruding from the biopsy needle carrier and the housing, is a knurled disk 80 , with which the position of the sampling space can be radially adjusted by turning without changing the position of the cutting sleeve. Twisting the biopsy needle alone involves twisting the sampling space and thus the sampling device. The plastic part 47 with the biopsy needle and cutting sleeve is pressed into the biopsy needle carrier with the bearing element 49 and the threaded spindle nut 75 . The biopsy needle is rotatably supported in the biopsy needle carrier and in the cutting sleeve via the bearing element 49 and its narrow guide in the cutting sleeve and can be displaced in the longitudinal axis with the biopsy needle carrier. As previously described, the cutting sleeve is axially movable relative to the biopsy needle by twisting.

To the right of the bearing element 49 , a polygon 50 is arranged on the plastic part, which can be latched to the biopsy needle carrier by tensioning, so that the sampling space of the biopsy needle can be brought and held in the most favorable position for biopsy removal by means of the knurled disk 80 .

Details of the sampling space and the biopsy needle tip are shown in FIGS. 11a-11e. The sampling space 71 adjoining the needle tip 70 is open above approximately 25% of its cross section. The sampling space is approximately 15 to 25 mm long. This is followed by the cavity of the biopsy needle. At the transition, i.e. at the right end of the sampling space, the cavity cross section of the biopsy needle is between 50% and 75% due to a restriction, e.g. B. closed a plug 79 ( Fig. 11b-11e). The height of the stopper is designed so that it extends downwards beyond the recess in the sampling space. As a result, the vacuum is primarily intended to pull the tissue sample into the sampling space with the continuous opening of the sampling space and to bring it into contact with the wall of the sampling space. If there is overpressure in the biopsy needle cavity, the constriction, the stopper, increases the pressure. The plug has a length of approximately 10 mm and is glued or welded into the cavity. Laser welding has shown that it is advantageous to thin the left side of the stopper by removing material from the end face to a short length, approx. 2 mm. As a result, the tube of the biopsy needle is welded to the end face of the plug in this area on the end face and is airtight on the end face. The stopper can also be of shorter length, provided the same effect is achieved. The plug can also be replaced by a lip or nose of approximately the same height. It is important that the constriction is designed in such a way that the vacuum in the sampling chamber is effective primarily from the bottom, so that the sample adheres to the wall of the sampling chamber during the cutting process and does not change its position. It has also proven to be advantageous to provide additional fixing means on the sampling wall. Sucking the sample into the sampling space from below results in a high degree of filling of the sampling space on the one hand and, on the other hand, particularly due to its design, a good fixation of the sample on the wall. Since the cutting sleeve separates the sample on the outside of the biopsy needle, this sticking of the sample inside remains even during the separation process. In addition, no tissue is sucked into the hollow cutting sleeve by the externally arranged cutting sleeve, due to the vacuum applied, and thus the tissue cannot be twisted or twisted by holding it in the interior of the cutting sleeve due to the rotating longitudinal movement of the cutting sleeve. The quality of the sample is improved because the pathologist receives a starting material that corresponds to the cross section of the cut and is not twisted or deformed. When the sample is ejected under pressure, the plug 79 additionally completely cleans the sampling space so that no mixing takes place in the event of repetition. Since the vacuum generating device is simultaneously used as a pressure generating device, the entire cavity, in particular the needle, is cleaned.

FIG. 13 shows the drive and the installation of the vacuum / pressure generating device 5 (view from the rear, that is to say against the Z axis, the housing cover and the lower housing part are omitted).

In the upper, rear, right area, the vacuum / pressure generating device 5 is arranged as a piston / cylinder unit 69 . It consists of a syringe body 52 with a threaded spindle 53 arranged therein, on the end of which facing the syringe base 51 a piston 54 with sealing elements - as is generally known in the case of syringes - is fastened (FIGS . 14a-14d).

At the end of the syringe body 52 facing the base block 8, a threaded spindle nut 48 with a gear wheel 55 formed on the circumference is arranged on the threaded spindle. The threaded nut has one or more threads. The threaded spindle 53 interacts with the threaded nut 48 . The spindle has a pitch of approx. 5 mm per gear, so that with each revolution the piston is moved out of the syringe body by the spindle drive by a precisely defined amount, i.e. away from the syringe base 51 or towards the syringe base, depending on the direction of rotation becomes. The toothed ring 55 arranged on the circumference of the threaded spindle nut meshes with the drive pinion 56 , which is fastened on the output shaft of the direct current geared motor 58 . The output shaft of the DC gear motor 58 is mounted in the base block 8 ; for this purpose, the output shaft is inserted into the cross plate 59 of the base block. If the DC gear motor 58 is activated, the piston is moved to the syringe base or in the direction of the base block 8 , depending on the direction of rotation. A high-speed DC motor is also used as the drive motor, followed by a high-speed planetary gear. It corresponds to the motor for the clamping device already described.

The piston 54 is designed in a known manner as a syringe piston. The syringe body made of plastic, a cylinder with a bottom, is transparent.

In order to prevent the threaded spindle 53 from rotating when the threaded spindle nut is driven, the two opposite surfaces 60 of the threaded spindle are flat ( FIG. 14d). The free end of the threaded spindle is inserted into the insert element. The distance between the surfaces of the threaded spindle corresponds to the width of the U-shaped insertion element 62 of the base block 8 . There is only a small amount of play between the U-shaped cross section of the insert element and the spindle surfaces on both sides. The threaded nut is supported on the base block.

In order to prevent the syringe body 52 from sliding out when the threaded spindle nut is rotated, the contact surface on the base block 8 is slightly conical downwards.

The nozzle 63 of the syringe body 52 is inserted into the passage 16 of the housing end cover 7 in such a way that the syringe body is held approximately in a horizontal position.

In order to make the twisting of the threaded spindle smooth, the threaded spindle nut with ring gear on the side facing the base block has a chamfer 66 approximately 1.5 mm thick. In addition, since the surface of the rib 59 on the base block 8 , which cooperates with the chamfer 66 of the threaded nut 48 , is inclined from top to bottom, the vacuum / pressure generating device is pulled down during operation. To generate a sufficient vacuum of approx. 200 hph in the sampling room, e.g. B. with a biopsy needle length of about 250 mm and an inner diameter of the hollow biopsy needle of about 5 mm, a syringe body for 20 ml with a length of about 90 mm is used. In order to be able to use the syringe body also as a pressure generator, a ventilation bore 67 of approximately 1.5 mm is provided after approximately x the length, corresponding to the stroke for generating the vacuum (position according to FIG. 11b). If the syringe plunger is moved through the vent hole 67 beyond (Figure 14c.), - if the vacuum is no longer required - is decomposed by supply of air (atmospheric pressure) through the vent hole 67, the previously established vacuum in the biopsy needle. If the direction of rotation of the geared motor is then reversed, the vacuum / pressure generating device in the system will build up excess pressure by moving the plunger (towards the syringe base), which causes the tissue sample to be ejected after the sampling space has been opened. Incidentally, the compressed air not only cleans the sampling space, but in particular also the interior of the biopsy needle. The plug narrowing the needle cavity makes it difficult or even completely impossible for tissue parts to enter the biopsy needle cavity. Due to the narrowing of the needle cavity by the plug 79 , the pressure at the sampling space is increased and the ejection of the sample is thereby improved, especially when the sampling space is half open.

The operation of the biopsy device is explained in more detail below:
The removable insert element 20 , consisting of a vacuum / pressure generating device, an elastic connecting element and a biopsy needle carrier with needle and cutting sleeve and other elements connected to it, as well as a guide roller 81 placed on the needle, is delivered in sterile packaging. The plunger 54 in the syringe body 52 is lifted slightly (1-2 mm) from the syringe base on delivery, the sampling space 71 of the biopsy needle 2 is open so that a visual inspection of the sampling space can be carried out before insertion. After opening the housing cover 10 , the carrier element 37 , including the biopsy needle 2 , cutting device 3 and other parts connected thereto, such as the vacuum / pressure generating device 5 connected to the connecting element 4 , is inserted into the connecting elements provided for this purpose ( FIG. 2). During the insertion process, care must be taken that the toothed wheel 74 engages in the teeth of the toothed roller 23 ; the cutting sleeve is inserted from above into the U-shaped holder 36 , at the same time the tabs 40 of the tensioning slide are inserted into the recesses 77 of the carrier element; the guide roller 81 is inserted into the feedthrough 13 so that the flanks 101 and 102 enclose the housing end cover 6 . The cutting sleeve is longitudinally displaceable and freely rotatable in the guide roller; however, the guide roller itself is no longer displaceable relative to the cutting sleeve after insertion into the housing end cover. The vacuum / pressure generating device is then inserted on the one hand into the upwardly open insertion element 62 of the base block 8 with the free end 61 and, on the other hand, into the U-shaped, upwardly open passage 16 with the connection piece 63 . The connecting piece 63 lies above the switching pin 19 . Since the insert element on the base block side has a clear width which just permits the insertion of the threaded spindle provided with surfaces 60 on both sides, the threaded spindle is held in the insert element in a rotationally secure manner. The toothed ring 55 of the threaded spindle nut 48 engages in the output pinion 56 of the geared motor after insertion. The distance between the base block on the one hand and the housing end cover 7 on the other hand is held in such a way that the syringe body 52 with a threaded spindle nut 48 placed on the syringe body finds just space. The unit syringe body and mounted gear is held so that it is not axially displaceable. After insertion, the vacuum / pressure generating device is parallel to the biopsy needle carrier; the connecting element describes an arc of approximately 180 °.

It would have to be added that the insertion takes place with the tensioning slide not tensioned; this means that the gear 74 engages at the right end of the toothed roller when the sampling space is open ( FIG. 3). After the correct insertion, the housing cover can be closed.

An insertion aid can be used to facilitate the insertion process. When the housing cover is closed, the connecting piece 63 is pressed down and the microswitch is actuated via the switching pin 19 built into the housing end cover. This activates the electrical system, which is indicated by the reset diode 91 flashing on the front of the handpiece. The reset diode first flashes green, which means that the positioning of the individual elements, ie the insertion process, has not yet ended; the DC geared motor 21 must first close the sampling space 71 with the cutting sleeve 3 (the sampling space was partially open when it was inserted). This is done by turning the threaded sleeve connected to the cutting sleeve. The cutting sleeve moves to the left until the gear 74 comes to rest on the inside of the holder 36 . The plastic disk 78 bears against the holder 36 (inside) after the sampling space has been closed. The DC geared motor 58 brings the syringe plunger 54 into contact with the syringe base 51 during this process or before or after. After the starting positions for the vacuum / pressure generating device and the biopsy needle / cutting sleeve have been reached, the clamping diode 94 and the sampling diode 92 light up green, the reset diode goes out. The operator must now decide whether to initiate tensioning of the tensioning slide or to take another sample, e.g. B. because he has previously taken a tissue sample. If the operator presses the tension button 90 , the tensioning of the tension slide is initiated; the span diode flashes green, the sampling diode 92 goes out. By pressing the tension button, the electrical direct current gear motor 21 receives current and the direct current gear motor drives the toothed roller 23 . The gear 74 meshing with the toothed roller 23 rotates the spindle shaft and at the same time the cutting sleeve 3 connected to it . Since the spindle nut 75 is pressed into the biopsy needle carrier 37 and the gear 74 is supported on the holder 36 via the plastic disk 78 , which is firmly connected to the housing via the base block 8 , the rotation of the threaded spindle sleeve 73 causes the biopsy needle carrier to be moved to the right , At the same time, the biopsy needle 2 connected to the biopsy needle carrier via the bearing element 49 is taken along, which leads to the biopsy needle tip migrating into the cutting sleeve. The biopsy needle carrier 37 is pushed over the recess / tab connection of the tensioning slide against the action of the spiral spring 31 to the right until the lever 33 of the latching element is pressed into the recess 82 of the tensioning slide by the spring 34 . The tension slide is locked in this position. The geared motor receives the control command that the locking position has been reached, e.g. B. via a recessed in the sliding surface of the cover plate, which cooperates with the retracted biopsy needle carrier; the direction of rotation of the motor is reversed and the cutting sleeve is turned back to the right by the amount by which the cutting sleeve had moved beyond the biopsy needle mushrooms by moving the tensioning slide and the biopsy needle. At the end of this step, the cutting sleeve closes the sampling space completely ( FIG. 11d), as at the beginning of the clamping process. The locking diode 95 lights up green; the flashing of the voltage diode 94 goes out. The plastic disk 78 is arranged between the gear 74 and the holder 36 so that the frictional force between the gear and the support element is reduced during the clamping process. Now the biopsy needle of the biopsy device z. B. inserted into a previously placed coaxial cannula. The proximal end of the inserted coaxial cannula contains a seal that is dimensioned such that it seals the space between the cutting sleeve and cannula on the one hand, and on the other hand allows the biopsy needle with cutting sleeve to be easily inserted. The sealing ring prevents air from being sucked in from outside via the space between the cannula and the cutting sleeve.

The sealing ring also prevents liquid (cytological material) from escaping after the biopsy needle has been inserted or shot in. So the possibility of contamination of the disinfected handpiece is almost avoided; on the other hand, the flank 101 of the sterile guide roller 81 prevents contamination of the sterile cannula from the handpiece. The biopsy needle tip is brought up to the tumor in the cannula and injected into the tumor after correct positioning.

The shot is triggered by pressing the actuation button 88 . The consequence of this is that the clamping slide is released by pivoting the double-armed lever 33 about the axis 35 . The tension slide is thrown to the left by spring action. The sampling diode lights up green, the span diode goes out. By pressing the program button 89 , the procedure for sampling is released; the sampling diode 92 flashes green. First, the DC gear motor 58 of the vacuum / pressure generating device is activated. The piston of the vacuum / pressure generating device is moved in the direction of the base block, ie away from the syringe base, until it reaches a position shortly before the ventilation bore 67 is released ( FIG. 14b). The vacuum in the system has been created. After reaching its end position, the system activates the motor 21 , the cutting sleeve, which closes the sampling space, is opened via the gear / spindle drive. During the opening process, the tissue and any cytological fluid (cytological material) are sucked into the sampling chamber one after the other due to the negative pressure in the system. Cytological fluid will also flow through the vacuum into the biopsy needle cavity and into the vacuum / pressure generating device. It has proven to be advantageous that the negative pressure is directed to the lower area, the lower side, of the sampling space by the stopper ( 79 ) and that the penetration of the tissue into the hollow biopsy needle is made more difficult or prevented by the stopper 79 , If the sampling space is completely open - the tissue sample is stored in the sampling space - the gear motor 21 is reversed and the sampling space 39 is closed. By turning the cutting sleeve, the tissue is separated by the cutting edge 72 of the cutting sleeve 3 during the closing process. Due to the special design of the sample collection space and due to the vacuum applied, the tissue sample is held in the sample collection space in a rotationally secured manner, so that the tissue sample, as described, is not twisted or twisted by the cutting sleeve 3, which is rotatably longitudinally displaceable around the outside of the biopsy needle. After the sampling space is closed, the DC gear motor for the vacuum generating unit 5 is activated. The piston 54 is first retracted until the piston clears the ventilation hole ( FIG. 11c). After the vacuum in the system has been released, the piston moves so far to the vacuum floor that the ventilation hole is closed again to prevent the outflow of body fluid (cytological fluid). The flashing of the sampling diode 92 goes out. The ejection diode 93 lights up green. The biopsy needle with the closed sample room is pulled out of the cannula. After the biopsy unit has been removed and a vessel has been made available for holding the tissue sample and liquid, the program button 89 is actuated again and the ejection diode 93 starts to flash. First of all, the geared motor 21 of the cutting sleeve is actuated in order to open the sampling space approximately up to half. Thereafter, the DC gear motor 58 of the vacuum / pressure generating device is activated. The direction of rotation of the direct current geared motor 58 remains and the threaded spindle 53 with the piston moves in the direction of the syringe base, so that an overpressure now arises in the system. The piston is advanced to the piston head, the drive motor 58 is deactivated. The gear motor 21 retracts the cutting sleeve above the sampling space after the piston has reached the piston head. As a result of the excess pressure built up in the system, the sample is pressed under pressure into a ready-to-use laboratory vessel when the sampling space is half open, and at the same time tissue and liquid are removed from the vacuum / pressure generating device, the biopsy needle and the sampling space. The sample is ejected when the sampling space is approximately half open because this ensures that the tissue sample is ejected and that the tissue sample does not fall back into the sampling space due to the premature relief of the excess pressure. The narrowing of the biopsy needle cavity by the plug 79 , which has made it difficult or prevented for tissue to penetrate into the biopsy needle cavity, proves to be particularly advantageous during sampling, since the narrowed cross section increases the ejection pressure. The best ejection results were therefore achieved with the sampling room half open; ie the cutting sleeve frees up half of the sampling space. Due to the overpressure, the tissue fluid is also pressed out of the sampling space and cleaned.

After the sampling space is completely open, the sampling and cleaning is complete, the ejection diode goes out. The reset diode 91 lights up green. If no further sample is to be taken, the housing cover is opened and the removable element 20 is removed. When the housing cover 10 is opened, the system is deactivated via the microswitch 18 . However, if a further sample is to be taken from the same tissue environment, the operator presses the program button 89 and the reset diode 91 starts to flash. The setting of the vacuum / pressure generating device, such as the cutting sleeve, takes place again as described. When the process is complete, the reset diode 91 goes out and the sampling diode lights up. The following process steps run in the order already described. The process can be repeated any number of times. After completion, the operator only has to decide whether he wants to take another sample or whether the sampling is complete and the housing cover is opened.

Should it be necessary for the sample to be taken from a point on the tumor that is not directly above or at the sample removal area after the injection, e.g. B. laterally therefrom, the position of the sampling space 71 can be rotated via the knurled screw 80 . In order for the operator to be able to recognize this radial position of the sampling space, a mark in the form of a notch 119 is made on the knurled wheel, which points upwards when the opening of the sampling space points upwards. In the respectively set position, the biopsy needle is fixed in the carrier part by the surfaces of the polygon 50 and the elastic forces. The sampling procedure is the same as described above.

After the end of the biopsy, after the cover is unlocked, the exchangeable element 20 (vacuum / pressure device, biopsy needle / cutting device with all the elements arranged thereon) is removed upwards. In order to make it impossible to open the housing when the tensioning slide is tensioned, a securing wing 84 is arranged on the biopsy needle carrier, which, when tensioned, bears against the left end face 85 of the closure device. As a result, the closure device which can be displaced in the X-axis can no longer be moved to the left in the open position and thus the nose 12 can no longer be removed from the recess 45 . Conversely, the housing cover cannot be closed if the carrier unit has been inserted when it is tensioned, since the safety wing prevents the bolt from being inserted into the space provided. The surface 85 of the bolt abuts the security wing. The battery charging diode 96 is switched off as soon as the housing cover is opened. When the lid is closed and the insert element 20 is inserted, the battery charging diode indicates whether there is sufficient energy.

Basically, it is conceivable that all steps for taking a sample as well as the Tensioning the sled, etc. by activating and deactivating the two Geared motors can be individually controlled by hand. But it is useful that individual steps of the process are summarized and automatically expire and only the initiation of the subsequent step by operating the switch is set. This semi-automatic method, as previously described, has proven to be proven particularly advantageous.

There are basically two methods for recording the actual values for comparison with the target values. One method is based on measuring the length displacement of the threaded spindle when pulling it out or pushing it in, and measuring the axial displacement of the cutting sleeve or the biopsy needle carrier. In order to detect these changes, photocells or microswitches are arranged inside the housing, in particular on the extension of the base block 8 . A positioning finger 103 is additionally placed on the cutting sleeve, while in the threaded spindle of the vacuum / pressure generating device the free end 61 protruding from the piston unit can be used as a measuring point, provided that the front edge of the biopsy needle carrier is used as a measuring point with a photocell, no additional is required positioning finger. The embedded photo cells are covered with a suitable, transparent material due to possible contamination. The positioning finger 103 passes through a slot in the biopsy needle holder. At corresponding points, on the extension 46 of the base block 8 , recesses 107 are provided, into which photocells or microswitches are installed, which interact either with the free end 61 of the piston spindle, with the position finger or with the biopsy needle carrier edge 120 ( FIG. 15). These signals (actual value) are processed in the electronics and form the control signals.

The other system is based on measuring the number of revolutions of the DC motors. Here, an encoder is placed on the shaft of the DC motor, which cooperates with a photocell placed on the housing of the DC motor. This measures the number of revolutions of the engine. Since the DC motors are load-dependent at a speed of approx. 10,000-12,000 rpm. work and on the other hand the downstream planetary gear arranged on the output side, which interacts with the spindle drive and considerably reduces the number of revolutions, precise longitudinal control is possible. The longitudinal displacement by the spindle drive is always an equal amount proportional to the output revolution and is therefore sufficient as a control signal for the longitudinal displacement. In order to precisely determine the position of the cutting sleeve 3 and the piston 54 at the beginning, that is after inserting the removable element and closing the housing cover 10 , the direct current gear motor 58 rotates the piston 54 to the stop on the syringe base and the direct current gear motor 21 brings the cutting sleeve drive to zero -Position by bringing the gear 74 against the threaded spindle nut 75 (the threaded spindle nut 75 runs onto the gear 74 ). From this zero position, the control of the individual steps is then carried out via the default / actual comparison. The necessary cables from the encoder to the electronics are housed in the housing, as is the circuit board with the electronic components.

In order to be able to use the exchangeable insertion unit easily, the insertion aid shown in FIGS . 16, 17) can be used. Coming in particular from FIG. 16, point 17, the biopsy needle carrier of two tabs 108 and comprises axially fixed in the holder by an additional land 109, so that it parallel to the vacuum / pressure device in the insertion aid to lie. The vacuum / pressure generating device is likewise encompassed on the one hand by the tab 116 and on the other hand by the centrally arranged tab 108 . In addition, a pin 110 engages in the ventilation hole 67 . This ensures that the vacuum / pressure generating device is aligned parallel to the biopsy needle carrier ( FIG. 1). The parts aligned in this way are fixed in the insertion aid in such a way that they can be easily inserted into the handpiece from above by means of the holding pieces 117 . Since the parts are packaged sterile with insertion aid, the replacement element 20 can be removed from the packaging without manual touch and inserted sterile into the handpiece 1 . The tabs are slightly chamfered to make it easier to hold the vacuum / pressure generating device and the biopsy needle holder. Since the insertion aid is made of plastic, the parts to be picked up can be easily held by clamping through appropriate choice of tolerance and flexibility. Parts list 1 handpiece
2 biopsy needle
3 cutting sleeve
4 connecting element
5 vacuum / pressure generating device
6 housing end cover (left)
7 housing end cover (right)
8 base block
9 lower housing part
10 housing cover
11 locking latch
12 nose
13 implementation
14 hole
15 implementation
16 Implementation
17 cones
18 microswitches
19 switching pin
20 removable element
21 DC geared motor
22 wall
23 tooth roller
24 U-shaped room
25 wall
26 block
27 groove
28 tension slides
29 threaded hole
30 bolts
31 coil spring
32 end piece
33 double lever
34 compression spring
35 axis
36 bracket
37 biopsy needle holder
38 holes
39 -
40 tabs
41 Surface slide carriage
42 Extension of the area
43 sliding surface
44 area of block 26
45 recess
46 cover
47 plastic part
48 lead screw nut
49 bearing element
50 polygon
51 syringe base
52 syringe barrel
53 lead screw
54 pistons
55 gear (ring gear)
56 drive pinion
57 circuit board
58 DC geared motor
59 cross plate
60 areas
61 free end
62 insert element
63 sockets
64 spouts
65 recess
66 Chamfering
67 ventilation hole
68 -
69 piston / cylinder unit
70 needle tip
71 sampling room
72 cutting edge
73 lead screw sleeve
74 gear
75 lead screw nut
76 sealing element
77 recesses
78 plastic disc
79 stoppers
80 knurled wheel
81 Leadership role
82 recess
83 metal part
84 safety wings
85 end face
86 -
87 midrib
88 actuation button
89 program button
90 tension button
91 reset diode
92 sampling diode
93 ejection diode
94 voltage diode
95 locking diode
96 battery charging diode
97 Implementation
98 implementation
99 arm of the double-armed lever
100 part of the lever
101 flanks of the guide roller on the left
102 flanks of the guide roller on the right
103 position fingers
104 axis
105 drive device (vacuum)
106 drive device (biopsy needle, tensioning device)
107 recesses
108 tabs
109 bridge
110 pen
111 Aku
112 plastic part
113 area
114 partition plate
115 pilot hole
116 attachment
117 holding pieces
118 -
119 notch
120 needle carrier edge

Claims (49)

1. Biopsy device consisting of a handpiece into which a hollow biopsy needle is inserted, a part of the part of the biopsy needle projecting beyond the handpiece with its sampling space being insertable into the tissue to be examined and the tissue being sucked into the sampling space by means of vacuum and then sucked in by means of a Sample separation device is separated and then removed, characterized in that the vacuum generating device is used if necessary to generate an excess pressure and the vacuum / pressure generating device ( 5 ) and further control and supply devices are integrated in the housing of the handpiece ( 1 ), and the connecting element ( 4 ) from the biopsy needle ( 3 ) to the vacuum / pressure generating device ( 5 ) is arranged directly on the housing and thus the freedom of movement of the handpiece is not impeded by lines or cables leading to external supply devices. 2. Biopsy device according to claim 1, characterized in that the vacuum / pressure generating device ( 5 ) consists of a piston / cylinder unit ( 69 ) which has a ventilation option. 3. Biopsy device according to claim 1 and 2, characterized in that the vacuum / pressure generating device ( 5 ) is a syringe / piston unit which has a ventilation bore ( 67 ) in the upper part which is used to break down the vacuum by withdrawing the syringe piston ( 54 ) is opened. 4. Biopsy device according to claim 1 to 3, characterized in that the piston ( 54 ) of the vacuum / pressure generating device ( 5 ) by means of a controllable spindle drive ( 53 , 48 ) is movable in both directions. 5. Biopsy device according to claim 4, characterized in that a high-speed electric DC motor ( 58 ) with a downstream planetary gear is used as the drive for the controllable spindle drive ( 53 , 48 ). 6. Biopsy device according to claim 5, characterized in that the transmission of planetary gear output to the piston spindle ( 53 ) takes place via a single-stage toothed gear, the threaded spindle nut ( 48 ) placed on the syringe cylinder carrying a ring gear ( 55 ) on the outside. 7. Biopsy device according to claims 1-5, characterized in that the piston ( 54 ) for generating a vacuum in the system and in the sampling space is moved in a first step away from the syringe base ( 51 ) until just before the ventilation hole ( 67 ). 8. Biopsy device according to claims 1-5, characterized in that for venting the system, the piston ( 54 ) is withdrawn in a second step following the first step via the ventilation bore ( 67 ), and after the vacuum has been released, it is moved back again by the Close ventilation hole. 9. Biopsy device according to claims 1-5, characterized in that the piston ( 54 ) is moved in a third step following the second step in the direction of the syringe base ( 52 ) in order to generate an overpressure in the system and in the sampling space. 10. Biopsy device according to one or more of the preceding claims, characterized in that the electric gear motor ( 58 ) of the piston / cylinder unit ( 69 ) is controlled via a speed measurement so that the piston ( 54 ) in a first step out of the cylinder just before the ventilation hole ( 67 ) is withdrawn, the ventilation hole ( 67 ) is released in a second step and the ventilation hole is closed again after the vacuum has been released, and in a third step in the opposite direction to generate the excess pressure to the syringe base ( 51 ) in coordination with control of sampling and ejection of the sample is moved. 11. Biopsy device according to one or more of claims 4-10 characterized in that the number of revolutions of the DC motor by a photocell fixed to the motor and one on the motor shaft arranged encoder is measured. 12. Biopsy device according to claim 11, characterized in that the Number of revolutions of the motor with a speed previously saved in the electronics Target value compared used as a trigger for the control of the spindle drive becomes. 13. Biopsy device according to claim 1 and 2, characterized in that the interior of the hollow biopsy needle ( 2 ) via a connecting piece ( 4 ) with the interior of the vacuum / pressure device ( 5 ) is connected so that no air flows in from outside under vacuum or can flow out at overpressure. 14. Biopsy device according to claim 13, characterized in that the connecting piece ( 4 ) is a flexible tube arranged in the immediate vicinity of the handpiece ( 1 ). 15. Biopsy device according to one or more of the preceding claims, characterized in that the biopsy needle carrier ( 37 ) with the round, hollow biopsy needle ( 2 ) and the cutting sleeve ( 3 ), which also coaxially surrounds the biopsy needle, and parts of the drive, the connecting element ( 4 ) and the vacuum / pressure generating device ( 5 ) form a removable, replaceable element ( 20 ) which can be inserted into the handpiece ( 1 ). 16. Biopsy device according to claim 15, characterized in that the removable biopsy needle carrier ( 37 ) can be inserted into the tabs ( 40 ) of the tensioning slide ( 28 ) by means of the recesses ( 77 ). 17. Biopsy device according to claim 16, characterized in that the tensioning slide ( 28 ) is brought into the tensioning position by means of a spindle drive ( 73 , 75 ) driven by means of a DC geared motor ( 21 ) with a downstream single-stage gear ( 23 , 74 ). 18. Biopsy device according to one or more of the preceding claims, characterized in that the clamping slide ( 28 ) can be mechanically locked in the clamping position. 19. Biopsy device according to one or more of claims 15-18, characterized in that a toothed roller ( 23 ) is seated on the output shaft of the planetary gear connected downstream of the direct current geared motor, into which the toothed wheel ( 74 ) of the spindle drive ( 73 ) connected to the cutting sleeve ( 3 ) , 75 ) engages. 20. Biopsy device according to claim 19, characterized in that the gear ( 74 ) placed on the spindle drive ( 73 ), ( 75 ) is supported upon displacement of the tensioning slide ( 28 ) on a holder ( 36 ) of the base block ( 8 ). 21. Biopsy device according to claim 17, characterized in that the drive for the tensioning slide is also used as a drive for the cutting sleeve ( 3 ). 22. Biopsy device according to one or more of the preceding claims, characterized in that the biopsy needle ( 2 ) with coaxial cutting sleeve ( 3 ) and further elements arranged thereon in the biopsy needle carrier ( 37 ) are held at two bearing points ( 75 , 49 ) so that the Biopsy needle ( 2 ) and / or the cutting sleeve ( 3 ) are individually rotatable. 23. Biopsy device according to one or more of the preceding claims, characterized in that the piston / cylinder unit ( 69 ) is designed such that in the system, consisting primarily of the cavity piston / cylinder unit ( 69 ), the hollow biopsy needle ( 2 ) and the hollow connecting piece ( 4 ), a generated vacuum in the order of magnitude of 200 hph is applied in the sampling space ( 71 ). 24. Biopsy device according to claim 1), characterized in that the cross-sectional biopsy needle ( 2 ) is surrounded by a coaxial cross-sectional cutting sleeve ( 3 ), the front edge of which has a cutting edge ( 72 ). 25. Biopsy device according to one or more of the preceding claims, characterized in that the cross section of the biopsy needle in front of the sampling space has a constriction ( 79 ) which covers the opening of the cross section of the sampling area from above ( FIG. 11e). 26. Biopsy device according to claim 25, characterized in that the constriction comprises 60-75% of the cross section and that the constriction projects into the cross section from above ( FIG. 11e). 27. Biopsy device according to claim 26, characterized in that the Narrowing is an approx. 10 mm long plug. 28. Biopsy device according to claim 26, characterized in that the Narrowing as a lip or nose protruding into the cross-section is trained. 29. Biopsy device according to one or more of the preceding claims, characterized in that only about 25% cross-section of the sampling space ( 71 ) are open at the top. 30. Biopsy device according to claim 29, characterized in that in Sampling room additional center, such as. B. pimples Adhesion improvement of the sample are arranged. 31. Biopsy device according to claim 22, characterized in that the threaded spindle nut ( 75 ) of the threaded spindle sleeve ( 73 ) is pressed into the biopsy needle carrier ( 37 ) and forms one of the two bearing points. 32. Biopsy device according to one or more of the preceding claims, characterized in that a base block ( 8 ) is arranged in the center of the inner housing, which is used for fastening, as well as for supporting, storing and holding the individual components such as tension slide ( 28 ), biopsy needle carrier ( 37 ), vacuum / pressure generating device ( 3 ) and drive devices ( 105 , 106 ). 33. Biopsy device according to one or more of the preceding claims, characterized in that a microswitch ( 18 ) is integrated in the housing end cover ( 7 ) serving for the housing-side mounting of the vacuum / pressure device ( 5 ), when actuated the energy supply is released. 34. Biopsy device according to claim 33, characterized in that the switching pin ( 19 ) of the microswitch ( 18 ) is actuated by depressing the vacuum / pressure generating device ( 5 ) by means of the housing cover ( 10 ). 35. Biopsy device according to one or more of the preceding claims, characterized in that means are provided on the biopsy needle carrier ( 37 ) which prevent the housing cover ( 10 ) from closing when the tension slide is inserted and the biopsy needle carrier is inserted, or prevent the housing cover from opening when the housing is closed. 36. Biopsy device according to one or more of the preceding claims, characterized in that on the housing surfaces for fastening the Handpiece are provided on a positioning device. 37. Biopsy device according to one or more of the preceding claims, characterized in that the upper outer contour of the biopsy needle carrier ( 37 ) corresponds to the housing inner contour. 38. Biopsy device according to one or more of the preceding claims, characterized in that on the right end (proximal end) of the biopsy needle ( 2 ) a plastic part ( 47 ) with knurled disc ( 80 ) is non-positively attached. 39. Biopsy device according to one or more of the preceding claims, characterized in that the plastic part ( 47 ) has a polygon ( 50 ) which cooperates with the biopsy needle carrier ( 37 ) and upon rotation by means of the knurled disc ( 80 ) the biopsy needle ( 2 ) and so that the sampling space ( 71 ) is locked in the selected position in the biopsy needle carrier ( 37 ). 40. Biopsy device according to one or more of the preceding claims, characterized in that the space for the geared motors is separated from the rest of the space upwards by a cover ( 46 ) connected to the base block ( 8 ). 41. Biopsy device according to one or more of the preceding claims, characterized in that the battery / accumulator space is separated from the rest of the space by a separating plate ( 144 ). 42. Biopsy device according to claim 18, characterized in that a double-armed lever ( 33 ) which is adjustable about an axis ( 35 ) under spring pressure is used, on one arm ( 100 ) of which a compression spring ( 34 ) acts, and the other arm ( 99 ) engages in a recess ( 82 ) of the clamping slide ( 28 ). 43. Biopsy device according to one or more of the preceding claims, characterized in that the function display and control switch including the actuation button ( 88 ) are integrated in a circuit board arranged on the front front. ( Fig. 7) 44. Biopsy device according to one or more of the preceding claims, characterized in that the biopsy needle carrier ( 37 ) and the vacuum / pressure generating device ( 5 ) are comprised of tabs ( 108 ), ( 118 ) of an insertion aid and a web attached to the insertion aid ( 109 ) aligns the biopsy needle carrier ( 37 ) in the longitudinal axis and the vacuum / pressure generating device is aligned in the longitudinal axis by means of a pin ( 110 ) which engages in the ventilation bore ( 67 ). 45. Biopsy device according to claim 44, characterized in that the insertion aid has two holding pieces ( 117 ) on the upper side. 46. Biopsy device according to one or more of the preceding claims, characterized in that the connecting element ( 4 ) is connected to the biopsy needle ( 2 ) via a plastic part ( 112 ) rotatably mounted in the plastic part ( 47 ). 47. Biopsy device according to claim 46, characterized in that the plastic part ( 112 ) is sealed off from the plastic part ( 47 ) by means of an O-ring. 48. Biopsy device according to claim 15, characterized in that the removable element ( 20 ) is a sterile packaged unit. 49. A method for using the device according to claim 1 and one or more of the following claims, characterized in that
that after inserting the insert element and closing the housing cover, the electrical system is switched on and the basic position is generated.
that the tensioning process or the biopsy can be carried out by selecting and pressing the corresponding key
that the clamping slide is locked in the clamping position by pressing the clamping button
that after pressing the trigger button, the biopsy needle tip with the closed sampling space penetrates into the tissue to be examined
that when the sampling process is activated, the sampling process runs automatically
that after removal of the biopsy needle from the tissue, by activating the sample ejection process, the sample is thrown out with overpressure while the sampling space is approximately half open
that by reinserting the biopsy needle / cutting sleeve, the sampling can be repeated without clamping.