DE10235480A1 - 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 with drive elements into which a biopsy needle is inserted, whereby part of the over the handpiece protruding part of the biopsy needle with its sampling space can be shot into the tissue to be examined and the tissue to be examined Tissue sample using negative pressure in the opening of the sampling room penetrates and then by means of a longitudinally movable Sample separation device separated and in a further step the sample is taken from the sampling room.

From the GMS 202 04363.0 a method and a device for cutting out tissue is already known, in which the tissue is sucked into a sampling area of the biopsy needle under the influence of vacuum. With this device, the tissue is sucked in via the blunt longitudinal edge of the sampling space by the negative pressure and the tissue penetrates into the sampling space at different depths depending on the strength. Since the edges of the sampling space are blunt, the tissue is, as it were, bent over the edges and, if possible, drawn into the sampling space. The actual cutting out of the sample, which is sucked into the sampling space, takes place via a cutting device which surrounds the outside of the biopsy needle and which is pushed over the sampling space of the hollow needle so as to rotate in a longitudinally movable manner. The separated sample is first stored in the needle and held by the cutting sleeve. After the needle has been removed from the tissue and the subsequent opening of the sampling space, the sample is blown out using the vacuum generator to generate compressed air. In order to generate a vacuum in the hollow needle, a hand-piece into which the hollow needle is slidably integrated is connected via a flexible line to a vacuum generator arranged in the handpiece.

In the known biopsy device, penetrates the tissue sample to be removed with pressure support each depending on the tissue structure at different depths in the sampling room the biopsy needle and then using the cutting edge on the sample separation device of the cutting sleeve, which as the coaxial sleeve Surrounds the needle, cut lengthways. This known method works reliably with normal tissue. at hard and / or tough In contrast, tissue sampling is unsatisfactory because inserting or pulling the sample into the sampling space incomplete is. The filling volume in the sampling room is sufficient not the requirements; the reason for this could be that with tough and / or hard tissue, so to speak the long edges of the sampling room as a support for the Tissue act and thus bridging entry.

The invention is based, which To design sampling in such a way that even with hard and / or tough tissue the sampling of the pathological requirements in terms of size and tissue architecture Structure corresponds, i.e. the degree of filling of the sampling room should always be the same regardless of the structure of the fabric. Furthermore, the control of the drives Be designed to meet tax and security requirements enough.

The solution according to the invention is that by briefly, slightly, repeatedly moving the biopsy needle back and forth ( 2 ) during and / or after opening the sampling room ( 71 ) the long side edges of the sampling space 71 due to the negative pressure applied in the biopsy needle ( 2 ) support a lateral separation of the tissue and only then the sample is completely separated out by actuating the separation device.

Through the short forward and backward movement The biopsy needle becomes the tissue under the influence of negative pressure pulled against the cutting edge and as a result of the back and forth moving the sample removal space from the side given, so that the tissue after the separation easier in the Sampling room can be drawn. The degree of filling in the sampling room is therefore reliable even with hard and / or tough tissue, i.e. the fabric structure corresponds in size, weight and structure the required conditions. The shaking motion can vary depending on the construction of the drive with opening start and during of the entire opening process last for. This favors inserting the sample in the sampling space under vacuum, because the tissue is separated laterally from distal to proximal.

But also a brief shake after opening the Sampling room brings the desired effect. The shaking motion to open the tissue laterally also during opening and done afterwards. By forming the longitudinal edges of the sampling room the cutting process of the tissue is further improved.

If additional pressure is applied from the inside or outside during the shaking movement or during the entire sampling process, the cutting effect of the cutting edge or the cutting edges during the shaking movement is additionally increased. This external pressure can, for example, by pressing the ultrasound head fes or other compression devices are generated.

Since it is the biopsy needles For disposable items (disposable parts), the training of Cutting edges inexpensively and be simple. This is achieved by part (T) the wall thickness the sampling room e.g. milled out or otherwise removed. So the inner radius is a vertical edge in the Outer radius transferred, i.e. the cutting edge is through the outer wall and formed the inside edge.

The stroke and the number of forward and backward movements the biopsy needle is programmable Presets can be set in the microprocessor to achieve optimal results receive. Generally has a stroke of 2 mm and a 5 times shaking proven.

The shaking motion itself is thereby generated that the drive motor for the cutting sleeve and the tensioning of the tensioning device is used via the threaded sleeve the cutting device against the biopsy needle carrier and above the tension slide pull a short coil spring between the base block and the tension slide is arranged.

Once the gear of the lead screw however runs against the lead screw nut, the direction of rotation of the motor reversed and the coil spring pushes the tension slide back. On with the cutting sleeve connected pipe, the collar of which comes to rest on a holder coffins that the cutting sleeve cannot move to the right at will (open position), but this pulling movement is initiated. A 5 times repetition of the forward and backward movement around 2 mm has proven to be particularly advantageous.

This simple construction can the drive motor for opening and closing the cutting sleeve, also for stretching the biopsy needle for the shaking motion be used, which is not only the saving of additional drive units means, but also a crowded Allows construction.

The control of the drive motors by sensors which are arranged on the drive motors and which That's why delivering signals to a programmable microprocessor particularly suitable because of the chronological sequence and the length movement of the individual units of vacuum / pressure generator or cutting sleeve counting can be controlled precisely. This revolution count control is too particularly advantageous because both forward and backward movement of the individual elements feasible by reversing the drive motors are. Only during the tensioning process of the biopsy needle, which over the Drive motor for the cutting device takes place, the position measurement is via photocells communicated to the microprocessor.

For safety reasons, the program steps are "clamping" and "expectoration the sample "with a delay circuit Mistake. Thus the call of these program steps must be conscious be initiated.

When closing the cutting sleeve this is about 2 mm above the closed position moved towards the tip of the needle and then back to the closed position to be driven. This ensures that the fabric fibers completely severed and not in the cavity between the biopsy needle tip and cutting sleeve be pinched.

Below is an embodiment based on drawings described. It shows:

1 Biopsy device with opened housing cover (perspective)

2 Handpiece with the parts of the biopsy device arranged therein (without housing base and lid) and exchangeable biopsy unit; (in perspective)

3 Longitudinal section A – A through the biopsy needle in 1

3a Longitudinal section A – A through the biopsy needle in 1 (how 3 ) proximal part (enlarged)

3b Enlargement of section A in 3a

3c Enlargement of section B in 3a

4 Cross section B – B in 3 (left housing part}

5 Cross section C – C in 3 (right housing part)

6 right housing end cover (inside) with integrated microswitch

7 Front of the control panel

8a Base block in the X-axis seen from the front (perspective)

8b Base block in the X-axis seen from the rear (perspective)

9a Units of the biopsy device fixed to the housing without housing cover and base in the untensioned state

9b Locking device in the untensioned state (section A - A)

10a How 9 , however, tension slide in tensioned position

10b How 9a , but in a locked state

11a Biopsy needle tip side view

11b Longitudinal section through 11a (Sampling room open)

11c How 11b , however (sampling room half open)

11d How 11b (Sampling space closed by cutting sleeve)

11e Section A – A in 11a

11f Section BB in 11a

11g Enlargement of the cut edge at A

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

13 Vacuum / pressure device, installation and drive (seen from behind, perspective)

14a Vacuum / pressure device with pistons placed on the syringe base (starting position for vacuum generation and end position for pressure generation, partially cut open)

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

14c Release of the ventilation hole; (syringe plunger retracted via the ventilation hole; pressure compensation position, partially cut open}

14d Section A - A through the threaded spindle in 14c

15 Base block and biopsy needle / cutting sleeve, prepared for the assembly with photocells and microswitch for the actual value acquisition

In the interior of a handpiece 1 all devices necessary for performing a vacuum biopsy are integrated ( 1 ), so that no cables or wires from the housing of the handpiece to other external supply devices are required. The handpiece 1 thus represents a complete vacuum biopsy device that is freely movable in all directions. From the distal housing end cover 6 protrudes the distal part of the hollow biopsy needle 2 with the cutting sleeve surrounding it coaxially 3 used to take the tissue sample. Usually a coaxial cannula is inserted into the tissue at the beginning of the biopsy, into which this part of the biopsy needle is inserted 2 with cutting sleeve 3 is introduced. Outside the right proximal end cap 7 is a connecting element 4 guided, for example a transparent, flexible hose, the vacuum / pressure generating device arranged parallel to the biopsy needle 5 with the inner cavity of the biopsy needle 2 combines. The hollow connector 4 is in the immediate vicinity of the housing end cover 7 arranged. The one in a biopsy needle holder 37 arranged biopsy needle with cutting sleeve and other elements forms with the connecting element 4 and the vacuum / pressure generating device 5 an easily removable and insertable element 20 which is changed as needed ( 2 ). For this, the housing cover 10 open. How in particular 2 shows, the biopsy device can be divided into parts that are firmly connected to the housing (disinfected parts) and into a removable element 20 (sterile part)). While the parts firmly attached to the housing are only disinfected, the removable element 20 Delivered sterile and renewed as needed, especially for every new patient.

In the embodiment described below is the vacuum / pressure generating device arranged parallel to the biopsy needle. Within the scope of the invention however, the vacuum / pressure generating device is also in the axis of the Biopsy needle or handpiece be arranged horizontally; there is also no need for a separate connecting element, if they e.g. placed directly on the end of the biopsy needle is.

Between the left and right housing end covers 6 . 7 there is a lower housing part 9 and a housing cover pivotally mounted in the housing end covers 10 with a locking latch 11 , Via tie rods or screws, some of which are in a base block 8th are screwed in, the lower part of the housing 9 between the housing end covers 6 . 7 jammed, or with the base block 8th connected. The housing cover 10 is over one in the housing end covers 6 . 7 attached axis pivotally connected. The housing cover 10 is closed before operating the biopsy facility; the inner contour of the housing cover corresponds to the outer contour of the biopsy needle carrier described in more detail later 37 , The base block is located approximately in the center of the housing interior 8th arranged, which is firmly connected to the lower housing part, for example via fixing elements and / or via a screw connection. With the basic block 8th , which extends not only in the longitudinal axis from the center to the left, but also over the entire transverse surface, are the drive elements for the vacuum / pressure generating device 5 who have favourited Cutting sleeve 3 and the clamping device for the clamping slide 28 on which the biopsy needle holder 37 is attached, connected. Furthermore, the base block points 8th a bracket open at the top 36 for the biopsy needle / cutting sleeve and another insertion element 62 for the vacuum / pressure generating device.

Zui description of the position of the individual elements, as well as the position of the individual parts, especially in the interior of the housing, was in 1 a coordinate cross is drawn, the coordinate center of the coordinate system in the center of the base block 8th ( 1 ) lies. 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, the top is in the direction of the Y axis, the bottom is opposed to the Y axis and the back in the direction of the Z axis, and the front opposite to the Z axis ( 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.

With regard to these specifications, the common types are located approximately in the lower, front, left housing part of the housing interior drive devices 106 for the clamping device and the cutting sleeve as well as the drive device in the lower, rear, left housing part 105 ( 13 ) for the vacuum / pressure generating device 5 , The lower right part contains the energy supply for the drive motors and other electrical equipment, such as for the control and / or monitoring elements; batteries or a rechargeable battery are preferred for this 111 , for example a 7.2 V lithium-ion battery, 1 Ah. The front, right, upper, interior of the housing lying above the battery compartment is largely used for the tension slide 28 used with locking part ( 5 ); the one with a block 26 , the part of the base block 8th is connected. The battery room is up through a partition plate 114 sealed.

In the uppermost, front part of the interior of the housing is a U-shaped insert bracket that is open at the top 36 of the base block 8th and in the upward-facing, on both sides of the tension slide 28 arranged tab 40 insertable and removable biopsy needle holder 37 , in which the biopsy needle / cutting sleeve unit is rotatably mounted with drive parts, 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 the left end face of the biopsy needle holder is in the untensioned state 37 almost on the left end cover 6 in the tensioned state, the right end face on the right housing end cover 7 , "Almost the entire length" means that the biopsy needle holder is at least shorter than the interior space required for the clamping process. If the tensioning path of the tensioning slide is 20 mm, for example, the biopsy needle holder must be able to be moved at least 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 largest possible span plus a few mm.

The clamping device (on the right, at the front) itself consists of one on a bolt 30 guided slide 28 , the bolt in the block 26 of the base block 8th can be screwed in. The bolt 30 is on the proximal side by a spiral spring 31 surround. On the distal side of the tension slide is another short spiral spring 124 on the bolt 30 arranged. This short coil spring is supported on the one hand on the block 26 and on the other hand on an inner lip 122 distal side in the tension slide. The spiral spring is supported on the opposite side (proximal side) of the lip of the tension slide 31 from. The locking device (see in particular 9b and 10b ) of the tension slide is on the block 26 attached. 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 housing cover, the lower housing part, the Gehäuseenddeckel and the base block are preferably made of aluminum.

The handpiece 1 consists, as already described, of a housing which consists of a lower housing part 9 with differently raised walls on the sides, housing cover adapted to the lower part of the housing 10 with longitudinally movable locking bar 11 and the two housing end covers 6 , and 7 is formed. The lower part of the housing is connected to the two end caps via tie rods or screws, eg made of iron, some of which are directly in the base block 8th be screwed in. The housing is approx. 200 mm long, the housing end covers have an approximately square cross-section, approx. 40 × 40 mm, ( 2 ). The housing cover 10 is about an axis 104 pivotable in the housing end caps 6 . 7 is attached; the holes in the housing end covers are used for this 14 , The nose 12 of the locking bar 11 is in the recess 45 of the base block 8th can be inserted to close the housing cover. The left housing end cover 6 has a U-shaped bushing open at the top in the front part 13 for the protruding part of the biopsy needle / cutting sleeve 2 . 3 and the leadership role placed on it 81 on. The rear end cover 7 has two U-shaped bushings open at the top 15 . 16 on. The implementation 15 corresponds to the implementation 13 ; it takes the end of the cross-sectional plastic part placed on the hollow biopsy needle 47 on. In the implementation 16 becomes a neck 63 the vacuum / pressure generating device ( 2 ). One in the plastic part 47 inserted, further plastic part 112 has a pin 17 on that to connect the connecting element 4 with the spout 64 serves the vacuum / pressure generating device. The inner cavity of the biopsy needle is via the likewise hollow connecting element 4 continuously connected to the cavity of the piston / cylinder arrangement and the cavity of the vacuum / pressure generating device. 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. How in particular 6 shows is in the implementation 16 of the housing end cover 7 a microswitch on the lower side 18 integrated, its switching pin 19 protrudes into the implementation.

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

On the front of the lower part of the housing 9 is an area 113 for the control panel attached to the housing ( 7 ) provided with the operating and monitoring elements. The control panel to be attached to the housing 57 is designed as a separate component, for example on the surface 113 of the lower part of the housing 9 is stuck on. This control panel is above lines 57 connected to other electronic components which are arranged in the housing, and to the power supply. Of the electrical-electronic components connected to the control panel, the one in particular is in the room 39 that is below the cover 46 lies to mention arranged circuit board. A programmable microprocessor and other electronic components are arranged on the board. The semi-automatic sequence control described in detail later is controlled by means of the microprocessor. The control panel mainly contains switches for operation and diodes for control. From a recess 65 The actuation button protrudes in the lower part of the housing and the control panel 88 for the mechanical release of the tensioned slide;
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, in particular, taking the sample by ejecting the sample. Accordingly, the actuation key 88 (Trigger} for the clamping slide to the right and the clamping button that triggers the clamping of the clamping slide 90 been put to the left. The program button intended for performing the biopsy 89 lies in the middle. The control lights for reset, performing the biopsy and ejecting the sample are also in the center after opening the sampling room. By pressing the program button 89 after inserting the removable element 20 and after closing and locking the housing cover and automatic setting of the basic position, two functions are called up, namely the sampling and the sample ejection. After inserting the removable element and closing the lid, the reset diode lights up briefly 91 yellow on and flashes while the home position is being set; after the initial position has been set, the reset diode goes out. The sampling diode 92 (green) and the clamping diode (yellow) light up, indicating that the operator can call up one or the other function. He presses the tension button 90 , so the tension slide 28 brought into the tensioned position and locked there. To prevent the tension button from being accidentally pressed, it is equipped with a delay switch, approx. 1.2 seconds. The yellow clamping diode flashes during the clamping process; after the tensioning process is completed, the locking diode (green) lights up; the device, the needle, is ready to enter the tissue to be examined by triggering it with the actuation key 88 to be shot. After the bullet, the locking diode goes out and the tension diode (yellow) and the sampling diode (green) light up. Both functions (clamping or sampling) can now be called up. When pressing the program button 89 the biopsy process is performed automatically, as explained later. However, the tensioning process could also be called up again. When the biopsy process (sampling) is called, it runs automatically. When the process is complete, the green flashing sampling diode goes out and the yellow ejection diode lights up. By pressing the program button again, the automated sampling procedure is carried out. When the process is complete, the flashing ejection diode goes out and the yellow reset diode lights up, which means that the removable element 20 can be removed, or that the device is automatically prepared for taking another sample by pressing the program button. Then the process follows again as already described, clamping etc. or taking a sample. When pressing the program button 89 for sampling (to eject the sample} a delay circuit is provided to prevent the ejection from happening if the program key is accidentally touched without the needle having been removed beforehand.

The battery charging diode 96 shows the charge status of the battery or accumulators. As already described, the diodes are switched in such a way that the diode flashes when the process called up is carried out and the diode of the subsequent process lights up when the process is complete. If two options are available, both subsequent diodes light up. The operator is then free to choose which one to make. The colors of the diodes are chosen so that processes in the tissue are shown in green, while processes outside are shown in yellow. Delay circuits (e.g. 1.2 - 1.5 seconds) are provided for the function clamping and sampling to ensure that the process was deliberately called. 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 8th (viewed from the front in the direction of the X axis) 8a ; the basic block 8th shows from behind in the X axis 8b (both representations in perspective). The basic block 8th seen in the longitudinal direction, it can be divided into two halves; the front part is used to attach the common drive for the cutting sleeve and clamping slide and in its upper part of the storage of the biopsy needle holder ( 8a ); the rear part is used to fasten the drive for the vacuum / pressure generating device and to mount one side of the vacuum / pressure generating device ( 8b ). Between the two drive motors 21 . 58 , under the midrib 87 is a central electronic board in the room below 39 arranged. The basic block 8th has a U-shaped space in its left front part 24 on which a toothed roller 23 by the gear motor 21 is driven, is installed. For this purpose, the output shaft of the geared motor is in an opening in the wall 25 of the base block 8th stored or inserted. The tooth roller 23 is attached to the output shaft and secured on it, for example by means of a screw, so that it cannot move and slide. On the other side is the tooth roller 23 in the wall 22 of the base block 8th stored. 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 is the toothed roller 23 placed.

On the wall 22 is another block pointing to the right 26 molded on both the pivoting double lever 33 for locking, as well as for fastening the bolt 30 for guiding the tension slide 28 serves. The bolt 30 is in the threaded hole 29 screwed. The tension slide 28 slides during the clamping process on the partition plate below 114 to the right. During the clamping process, it is on the threaded bolt 30 arranged coil spring 31 pressed together. The coil spring rests with one end on an end piece 32 the threaded bolt or directly on the housing end cover 7 from; the other end of the spiral spring, which protrudes into a blind hole in the tensioning slide, is supported by a washer on a lip 122 the guide hole 115 from. The threaded bolt 30 on the one hand in the housing end cover 7 and on the other hand in the block 26 attached, carries a short coil spring at its distal end 124 which is also located on its proximal side on the lip in one of the holes 115 opposite coaxial blind hole 129 via another washer 125 on the circumferential lip 122 supported. Both coil springs have the same diameter and the distal and proximal holes 129 . 115 in the tension slide and the distal bore 128 in the block 26 are designed in diameter so that the coil springs can be easily inserted. All holes are coaxial to the bolt 30 arranged. The threaded bolt points at the same height as the circumferential lip in the blind bore of the slide 30 a covenant 123 on. The tension slide 28 is in its starting position (rest position) by the slightly pre-tensioned springs 31 . 124 held in the rest position via the washers, as in 3a and 3c shown. The washers lie on both the corresponding side of the collar and the lip and are vertical; if the slide is deflected to the right or left, the respective spring will attempt to return the tensioning slide to its starting position, the tensioning slide is, so to speak, "floating".

The tension slide 28 mainly slides on the partition plate 114 and is secured against rotation by this and the side wall. An arm 99 of the double-armed lever 33 the locking device engages in a groove 27 of the tension slide 28 on ( 9a and 10a ). The in the block 26 of the base block 8th Integrated locking device consists of the double-armed lever 33 which is about a vertical axis 35 (seen in the Y axis) by means of a compression spring 34 is pivotable. The axis 35 , a vertical pin, is in the holes 38 of the base block attached. The part is in the untensioned state 99 of the double-armed lever in the groove 27 the tension slide; the compressed spring 34 affects the part 100 the lever around the lock button 88 to push outwards. Once the part 99 of the double-armed lever in the recess 82 of the tension carriage can be engaged, the actuation key 88 pushed outwards. The tension slide is activated by snapping the lever part into place 99 locked in the tensioned state and can now be pressed with the actuation button if required 88 to be triggered. Since the tension slide is expediently made of plastic, it has proven to be expedient to insert a metal part into the recess 83 to avoid damaging the plastic, since the double-armed lever is made of metal. In contrast to the removable element 20 the handpiece with exchanged insert 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 usually between 15 and 25 mm, the length of the lever can be designed accordingly 99 and corresponding changes in the control, the same handpiece can be used for different penetration depths.

The one on the block 26 subsequent tension slide 28 is level with the block 26 arranged and has approximately the same cross-section as the block 26 , The tension slide has two tabs on its upper side 40 on. The face up 41 of the tension slide, as well as the surface pointing upwards 44 of the block 26 , as well as the surface of the extension pointing upwards 42 of the base block 8th , together form a flat bearing surface for the lower sliding surface 43 of the biopsy needle holder to be attached 37 (Sh. 2 ). The biopsy needle holder is made of plastic. When the tension slide is shifted from the unstressed initial state ( 9a ) in the tense state ( 10a ), so to the right, it slides off the tabs 40 held biopsy needle holder 37 about the area 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 has been triggered 88 the biopsy needle can penetrate the tissue, the tumor, in a straight line. Therefore, the upper outer contour of the biopsy needle carrier is designed corresponding to 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 moving upward, which is also advantageous during the tensioning process.

Above the U-shaped room 24 for the tooth roller 23 , at the height of the sliding surface 42 , the base block shows 8th a U-shaped bracket that is open at the top 36 for inserting the biopsy needle / cutting sleeve. This holder mainly serves as a radial thrust bearing, that is to say for the support for the drive part connected to the cutting sleeve, the gearwheel 74 , or the plastic disc 78 around the tension slide by means of the drive device 106 to bring it into its clamping position, as will be described later.

In the rear, upper part of the base block is another U-shaped insert 62 provided into the free end protruding from the sprayer body 61 the threaded spindle of the vacuum / pressure generating device is inserted. In the middle, top, of the base block is an attachment for a plate that has the recess 45 picks up, provided in the nose 12 of the locking bar 11 of the housing cover is inserted. One on the base block 8th arranged cover 46 , which 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 mainly used for the storage of the exchangeable biopsy needle holder 37 , including biopsy needle and cutting sleeve. The cover 46 protects the electric geared motors and the circuit board from dirt. The circuit board for the electronics is located between the drive motors and below the center rib in the room 39 ,

The biopsy needle holder 37 that in the tabs 40 of the tension slide 28 with biopsy needle 2 and cutting sleeve 3 and other parts can be inserted, shows 2 , The hollow, circular biopsy needle 2 has a needle point 70 to which the sampling room is located 71 connects ( 11a - 11f ). The cross-sectional biopsy needle 2 is made of a coaxially arranged, cross-sectional cutting sleeve 3 surround a cutting edge at its left end facing the sampling space 72 has, which serves to cut out the tissue sample after insertion of the biopsy needle (with the closed sampling space) and after opening the sampling space and sucking the sample into the sampling space. The distally arranged cutting edge of the cutting sleeve 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. How in particular 11f shows in cross section, the longitudinal edges 68 of the sampling space above the center of the cross-section, ie the sampling space is raised by about 15-30 ° over the center. In order to improve the penetration of firm, hard tissue into the sampling space, the longitudinal edges have a cutting edge. This edge on the edges is created by the wall thickness around the piece of material T1 ( 11 ) is reduced. This connects the inner wall with radius ri to the outer wall with radius ra via a vertical surface or edge. The cutting edge thus forms the outer wall with the vertical edge.

On the cutting edge 72 The other, proximal end of the cutting sleeve facing away is a threaded spindle sleeve 73 with a gear arranged on the end face of the threaded spindle sleeve 74 attached. The threaded spindle sleeve with gear is arranged on the cutting sleeve so that it cannot rotate and move. A threaded nut works with the threaded spindle 75 together, firmly in the biopsy needle holder 37 is pressed. The gear 74 is on the left before the start of the spindle sleeve. When turning the threaded spindle sleeve using the gear 74 the cutting sleeve is rotated and in the longitudinal direction over the biopsy needle 2 postponed.

Distal side of the gear 74 is a piece of pipe with the threaded spindle 126 with the federal government 127 firmly connected. The pipe piece is in the holder 36 inserted, the federal government 127 here lies distally in front of the holder. The length of the pipe section 126 corresponds approximately to the span, with the additional wall thickness of the bracket 36 must be taken into account (see 3a and 3b ). The Bund 127 moves to the left, to the distal side when the device is in the basic position (closed sampling space), while it moves to the holder after opening the sampling space 36 (distal side) comes to rest. If the spindle sleeve with cutting device is turned further, i.e. when trying to open the sampling space further, which causes the tensioning slide to block against the action of the short spiral spring 26 is drawn. As described later, this allows the biopsy needle to be moved forwards and backwards.

The gear 74 at the left end of the threaded spindle combs after inserting the biopsy needle holder into the tabs 40 with the tooth roller 23 , Around the biopsy needle holder 37 when the slide is not tensioned ( 2 ) in the tabs of the tension slide, the biopsy shows delträger two flat, parallel recesses 77 on. When placing the sliding surface of the biopsy needle holder 37 on the surfaces 41 . 42 and 44 the cutting sleeve is simultaneously in the holder 36 of the base block 8th used. On the left side of the gear can improve the rotatability of the spindle drive, especially when the bracket 36 serves as a support for tensioning the tension slide, a plastic disc 78 be inserted, which is provided with a slight cone. When the biopsy needle carrier is correctly inserted, the biopsy needle carrier slides with the sliding surface when the tensioning slide is tensioned 43 over the areas 42 and 41 to the right. Since the sample collection space is closed after inserting the biopsy needle holder, the gearwheel lies 74 on the bracket 36 on. Now the tooth roller 23 driven further in the same direction, the threaded spindle drive screws the tension 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 gearwheel 74 shifts from left to right in the tooth 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 until the collar 127 comes to the plant.

The function of the “floating” tension slide in connection with the controllable drive motor and the pipe section connected to the cutting sleeve 126 with the federal government 127 is described in connection with the course of the biopsy.

The right end of the cutting sleeve is over a sealing element 76 with the hollow biopsy needle rotatable, but connected in an air-tight manner so that neither air can penetrate between the biopsy needle and the cutting sleeve surrounding it coaxially, nor can air escape at excess pressure. On the right end of the biopsy needle 2 is a round, also hollow plastic part 47 placed airtight and non-positively connected to the biopsy needle. The plastic part 47 has a bearing element at its left end 49 that is pressed into the biopsy needle carrier; at its right end protruding from the handpiece is another plastic part 112 used that against the plastic part 47 and opposite the biopsy needle 2 is rotatable. Between the biopsy needle and the plastic part 112 an O-ring is used for sealing. The plastic part has a pin on its right end 17 on which the connecting element 4 is pushed on airtight. There is also a knurled disc on the right, protruding from the biopsy needle holder and the housing 80 with which the position of the sampling space can be adjusted radially by turning without changing the position of the cutting sleeve. Twisting of the biopsy needle is only associated with twisting of the sampling space. The plastic part 47 with biopsy needle and cutting sleeve is used with the bearing element 49 and the lead screw nut 75 pressed into the biopsy needle carrier. The biopsy needle is over the bearing element 49 and its close guidance in the cutting sleeve rotatably mounted in the biopsy needle carrier and in the cutting sleeve and displaceable 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 is a polygon 50 arranged on the plastic part, which can be locked to the biopsy needle carrier by tensioning, the sampling space of the biopsy needle can be moved by means of the knurled wheel 80 placed and held in the most convenient position for biopsy.

Like in particular 12 shows, the cutting sleeve coaxially surrounding the biopsy needle is via the threaded nut 75 with the biopsy needle holder 37 connected. In the threaded nut 75 is the threaded spindle sleeve 73 rotatably mounted. A turning of the gear 74 by the drive motor of the tooth roller 23 causes the biopsy needle carrier and the tension slide to move to the right as soon as the gear 74 for attachment to bracket 3fi comes. If the gear is positioned within the length of the toothed roller 74 , so provided the gear is free and neither on the bracket nor on the threaded nut 75 is present, the cutting sleeve can be adjusted on its own, for example after tensioning the needle to compensate for the needle tip and cutting sleeve in order to be guided into the starting position, or to open and close the sampling space. The piece of pipe with collar attached to the distal side of the gear, that with the bracket 36 works together, in cooperation with the control system, to set the needle in a brief shaking movement (forward and backward movement). When driving the toothed roller is via the gear 74 the sampling room is opened until the collar on the holder 36 comes to the distal side. If this direction of rotation is now maintained and the gear wheel is not in contact with the threaded spindle nut, the further rotation causes the tensioning slide to block over the biopsy needle carrier 2fi is pulled against the action of the short spiral spring, since a further opening of the cutting sleeve is not possible due to the concern of the federal government. The span is approx. 2 mm. With the stop of the gear 74 on the threaded nut, the direction of rotation of the motor is reversed and with the support of the short spiral spring, the tension slide is pushed back into its starting position (rest position). Since a encoder counts the number of engine revolutions and the actual values are stored in a programmable microprocessor, the engine speed can be reversed according to the specifications, so that the tensioning slide is pulled against the block again or retracted after release. Due to the constant rotation of the direction of rotation of the motor, in accordance with the specification, in cooperation with the tensioning and releasing of the slide, the biopsy needle performs a shaking movement. Five forward and backward movements are generally sufficient to ensure good sampling even with hard and / or tough tissue. Due to the forward and backward movement of the biopsy needle in connection with the sharpened cutting edge, the tissue that is to be drawn into the sample collection space by the vacuum is severed at the side edges, which enables complete suction. The construction described enables the biopsy needle with the associated cutting edges of the sampling space to be shaken after the sampling space has been opened. The same effect is also achieved if this shaking movement is generated during opening, that is to say when the cutting sleeve is moved back, in order to reliably separate the tissue at the side edges. This shaking movement can be generated via electrical elements that are connected to the needle or the tensioning slide. For example, the toothed roller on the proximal side can carry a link, which interacts with a pin that abuts the tensioning slide so that when the gearwheel is rotated it carries out a shaking movement that is transmitted to the needle via a connection.

Details of the sampling space and the biopsy needle tip are in the 11a - 11g shown. The one at the tip of the needle 70 subsequent sampling room 71 is open above about 25% of its cross-section. With a biopsy needle outer diameter of 3.3 mm, the height N of the biopsy needle space is approximately 2.3 mm. The sampling space is approximately 15 to 25 mm long. This is followed by the cavity of the biopsy needle. At the transition, ie at the proximal end of the sampling space, the cross section of the cavity of the biopsy needle is between 50% and 75% due to a restriction, for example a stopper 79 locked ( 11b - 11e ). The height of the stopper is designed so that it extends downwards over the recess for the sampling space, ie how 11e shows, at the bottom of the sampling space is an opening with a height of 0.6 mm and an inner needle diameter of 3.0 mm. 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 the rotating longitudinal movement of the cutting sleeve by holding it in the interior 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 through the stopper 79 in addition, a complete cleaning of the sampling room takes place, 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. With normal tissue, it is sufficient to use the wall thickness of the biopsy needle tube of approx. 0.15 mm as the side cutting edge. In the case of hard and / or firm tissue, the degree of filling in the sampling space is not sufficient simply by vacuum suction. By designing the long sides of the sampling room 71 to cutting edges 68 as esp. 11g and 11f show, by superimposing a brief shaking movement (as described) and by the effect of pressure, for example by the vacuum, the tissue of the sample is separated lengthways, so that the vacuum can pull the sample much better to the bottom of the sampling space. By creating an egg external pressure, for example by means of the ultrasound head or another compression means, the cutting effect can be increased. By separating the lateral cut surfaces of the tissue sample to be removed, an excellent degree of filling is achieved even with hard and / or tough tissue, thus ensuring that sufficient material is made available for the examination. The cutting edge on the long side of the sampling device is formed in that the section (T1) is milled off by the wall thickness. The outer contour (ra) of the biopsy needle tube is retained, while the inner contour (ri) is transferred into the outer contour by, for example, milling out the section T1 via a vertical wall (see. 11g ).

An improvement in the feed process of However, the sample is already caused by the shaking process during the opening of the Sampling space and / or thereafter, the side edges in their original Design (i.e. without cutting edge) remain.

11d shows the closed sampling room in which the sample is located. The cutting sleeve has proven to be advantageous during the separation process 78 about their in 11d to move the end position shown in the distal direction approx. 2 mm and then to return the cutting sleeve to its end position again 2 mm. This scissor effect reliably removes fibers that have not yet been cut, which leads to a further improvement in the sample quality.

13 shows the drive and installation of the vacuum / pressure generating device 5 (View from behind, i.e. against the Z axis, the housing cover and lower housing part are omitted).

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

On the base block 8th facing end of the syringe body 52 is a threaded nut on the threaded spindle 48 with gear formed on the circumference 55 arranged. The threaded nut has one or more threads. The threaded spindle 53 works with the threaded nut 48 together. The spindle has a pitch of approx. 5 mm per gear, so that with each revolution of the piston by means of the spindle drive out of the syringe body, i.e. from the syringe base, by a precisely defined amount 51 away, or towards the syringe base, depending on the direction of rotation. The ring gear arranged on the circumference of the threaded spindle nut 55 meshes with the drive pinion 56 that on the output shaft of the DC geared motor 58 , is attached. The output shaft of the DC geared motor 58 is in the basic block 8th stored; this is the output shaft in the cross plate 59 of the base block. Will the DC gear motor 58 activated, the plunger becomes the base of the syringe or the base black, depending on the direction of rotation 8th moved there. 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. On the DC geared motor, therefore, a counting device is also attached on the distal side, which consists of a two-armed impeller 131 and a photocell installed on the motor side. The counting device is connected to the programmable microprocessor, so that the function of the vacuum / pressure device can be controlled via the number of revolutions, in that the functions can be called up after a starting value has been determined by programmable or programmed specifications.

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

To turn the threaded spindle 53 The two opposite surfaces must be prevented when driving the threaded nut 60 the threaded spindle is flat ( 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 insert element 62 of the base block B. There is only a slight 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.

To let the syringe body slide out 52 To prevent rotation of the threaded spindle nut is the contact surface on the base block 8th slightly conical downwards.

The stub 63 of the syringe body 52 is in the process of being implemented 16 of the housing end cover 7 inserted so that the syringe body is held approximately in a horizontal position.

In order to make the turning of the threaded spindle easy, the threaded spindle nut with ring gear has a roughly 1.5 mm chamfer on the side facing the base block 66 on. In addition, the area of the rib 59 on the base block 8th with the chamfer 66 the lead screw nut 48 cooperates, is inclined from top to bottom, the vacuum / pressure generating device is pulled down during operation. To create a sufficient vacuum of approx.

200 hph in the sampling room, for example with a biopsy needle length of approx. 250 mm and an internal diameter of the hollow biopsy needle between 3 and 5 mm, a syringe body for 20 ml with egg ner length of about 90 mm used. In order to be able to use the syringe body as a pressure generator, after about nach of the length, corresponding to the stroke for generating the vacuum (position according to 11b ) a ventilation hole 67 approx. 1.5 mm. The syringe plunger goes over the ventilation hole 67 moved out ( 14c ), - when the vacuum is no longer required - is supplied by air (atmospheric pressure) via the ventilation hole 67 the vacuum previously built up in the hollow biopsy needle is released. 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. To prevent the tissue sample from being accidentally ejected by pressing the program button 89 a delay circuit is integrated in the control, which only triggers the process after pressing for 1.2–1.5 seconds. The sample may only be ejected after the biopsy needle has been removed from the tissue, which is ensured in this way. 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. By narrowing the needle cavity through the stopper 79 the pressure at the sampling space is increased and the ejection of the sample is improved, especially when the sampling space is half open. When using the biopsy device, it is recommended to use a specially designed coaxial cannula that is tailored to the needs and requirements of the device. It must contain appropriate devices that prevent air from entering and hinder or prevent the escape of tissue fluid; on the other hand, it should be easy to insert into the tissue.

The operation of the Biopsy facility closer explains: The following functions can be distinguished in terms of the process, which run largely automatically after initiation:

• a) Starting and setting the home position
• b) Tension the biopsy needle and shoot it into the tissue
• c) cutting out the sample from the tissue (sampling)
• d) Taking the sample after removing the biopsy needle from the tissue was removed.

a) Start and adjust the basic position

The removable insert 20 , consisting of vacuum / pressure generating device, elastic connecting element and biopsy needle holder with needle and cutting sleeve and other elements connected to it, as well as a guide roller placed on the needle 81 , is delivered sterile packed. The removable elements (see 2 ) are held by an insertion aid, which is removed after insertion into the handpiece. This insertion aid 104 has two grips on the top and tabs 108 for holding the biopsy needle holder 37 and the vacuum / pressure generating device. To fix the position of the vacuum / pressure generating device (parallel to the biopsy needle holder} there is a pin to the bracket 110 provided, which is inserted into the ventilation hole.

The piston 54 in the syringe body 52 is slightly raised (1–2 mm) from the syringe base on delivery, the sampling room 71 the biopsy needle 2 is open so that you can carry out a visual inspection of the sampling room before inserting it. After opening the housing cover 10 becomes the biopsy needle holder, including the biopsy needle 2 , Cutting device 3 and other related parts, such as those on the connector 4 connected vacuum / pressure generating device 5 inserted in the connecting elements provided on the handpiece (see 2 ). When inserting, make sure that the gear 74 in the teeth of the tooth roller 23 engages; the cutting sleeve is inserted into the U-shaped holder from above 36 inserted, at the same time the tabs 40 of the tension slide in the recesses 77 the support element inserted; the leadership role 81 is in the process of being implemented 13 inserted so that they flanks 101 and 102 the housing end cover 6 include. 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 on the one hand in the insertion element open at the top 62 of the base block 8th with the free end 61 and on the other hand in the U-shaped, open-top passage 16 with the neck 63 inserted. The stub 63 lies above the switch pin 19 , Since the base block-side insertion element has a clear width, which is just the insertion of surfaces on both sides 60 provided threaded spindle, the threaded spindle is held in the insert element against rotation. The ring gear 55 the lead screw nut 48 grips after insertion into the output pinion 56 of the gear motor. The distance between the base block on the one hand and the housing end cover 7 on the other hand is held so that the syringe body 52 with threaded nut placed on the syringe body 48 just finds 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 be added that that Inserted when the tension slide is not tensioned; this means the gear 74 engages at the right end of the toothed roller with the sampling space open ( 3 ). After the correct insertion, the housing cover can be closed.

The insertion aid described can be used to facilitate the insertion process. However, the insertion can also be done without insertion aid. When you close the housing cover, the nozzle 63 pressed down while doing so via the switching pin built into the housing end cover 19 , the microswitch is actuated. This activates the electrical system, which is indicated by the flashing reset diode (yellow) 91 on the front of the handpiece. The reset diode flashes yellow, which means that the positioning of the individual elements, ie the insertion process, has not yet ended; the DC geared motor 21 must first have the sampling room 71 with the cutting sleeve 3 close (the sampling room was partially open when 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 near the inside of the bracket 36 comes to the plant. The plastic disc 78 lies on the holder after the sampling chamber has been closed 36 (Inside). The DC gear motor 58 brings the syringe plunger during or before or after 54 in contact with the syringe base 51 , The microprocessor counters for the movement of the needle / cutting sleeve and the vacuum / pressure generating device are also reset in this phase. From this basic setting, the programmed movement sequences take place via the counting device arranged on the two motors. After the starting positions for the vacuum / pressure generating device and the biopsy needle / cutting sleeve are reached, the clamping diode lights up 94 (yellow) and the sampling diode 92 (green) on, the reset diode goes out.

b) tensioning the biopsy needle and shooting the biopsy needle into the tissue

In this phase, the operator has to decide whether to initiate the tensioning of the tensioning slide or to take a sample, for example after another shot, a further tissue sample. The operator presses the tension button 90 , the tensioning of the tension slide is initiated; the tension diode flashes yellow, the sampling diode (green) 92 goes out. By pressing the tension button (because of the delay switching the button has to be pressed for approx. 1.2-1.5 seconds) the electric DC geared motor is given 21 Electricity and the DC gear motor drives the toothed roller 23 on. That with the tooth roller 23 meshing gear 74 turns the spindle shaft and at the same time the cutting sleeve connected to it 3 , Because the spindle nut 75 in the biopsy needle carrier 37 is pressed and the gear 74 itself over the plastic disc 78 on the bracket 36 supports that over the base block 8th is firmly connected to the housing, causes the threaded spindle sleeve to rotate 73 that the biopsy needle carrier is moved to the right. At the same time, the biopsy needle carrier is placed over the bearing element 49 connected biopsy needle 2 entrained, which causes the biopsy needle tip to migrate into the cutting sleeve. The biopsy needle holder 37 is against the action of the coil spring via the recess / tab connection of the tension slide 31 shifted to the right until the lever 33 of the locking element in the recess 82 of the tension slide by the spring 34 is pushed in. The tension slide is locked in this position. The geared motor receives the control command that the locking position has been reached, for example via a photo cell embedded in the sliding surface of the cover plate, which interacts with the retracted biopsy needle carrier; or via the microprocessor, on the one hand, compares the actual number of revolutions with the entered target number, which was previously programmed; 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 tip by moving the tensioning slide and the biopsy needle. At the end of this step, the cutting sleeve closes the sampling space completely ( 11d ), like at the beginning of the tensioning process. The locking diode 95 lights up green; the flashing of the tension diode 94 goes out. An additional plastic washer is used, for example, to reduce the frictional force between the gearwheel and the support element during the clamping process 78 between gear 74 and bracket 36 arranged.

Now the biopsy needle of the biopsy device is inserted, for example, 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 the cannula on the one hand, and on the other hand allows the biopsy needle with the 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. This virtually avoids the possibility of contamination of the disinfected handpiece, and on the other hand prevents the flank 101 the sterile leadership role 81 that the sterile cannula is contaminated by 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 made by pressing the actuation button 88 triggered. Gas pressure results in that by pivoting the double-armed lever 33 around the axis 35 the tension slide is released. The tension slide is thrown to the left by spring action. The microprocessor is informed of the triggering of the shot and the new position of the needle by, for example, an integrated photocell. The sampling diode lights up green, the span diode lights up yellow.

c) Cutting out the Sample from the tissue

By pressing the program button again 89 the procedure for sampling is released; the sampling diode 92 flashes green. First, the DC gear motor 58 the vacuum / pressure generating device 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 is released 67 reached ( 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 successively sucked into the sampling space by the negative pressure prevailing in the system. Cytological fluid will also flow through the vacuum into the biopsy needle cavity and into the vacuum / pressure generating device proved to be advantageous that the plug ( 79 ) the negative pressure is mainly directed to the lower area, the lower side, of the sampling space and through the stopper 79 penetration of the tissue into the hollow biopsy needle is made difficult or prevented. If the sampling space is completely open so that the sample can penetrate into the sampling space with the help of the applied vacuum, the biopsy needle is moved back and forth briefly, about 5 times, in the range of approx. 2 mm. This happens because of the drive motor 21 the microprocessor gives the command to open further despite the sampling room being open; however, this does not succeed because of the federal government 127 prevents further movement of the cutting sleeve to the right. Via the threaded spindle / threaded nut and the biopsy needle carrier element, however, the tension slide is shifted to the distal side by approx. 2 mm and the short spiral spring is compressed. The direction of rotation of the drive motor is reversed by the microprocessor control after a predetermined number of revolutions, which corresponds to the path of 2 mm. The tension slide is returned to its starting position by the coil spring and the motor. Then the drive motor is reversed again and the tension slide is pulled again against the action of the short spiral spring; after reaching the tensioning path, the reversal takes place and so on. This forward-backward movement can be repeated any number of times, depending on the programming. In general, 5 cycles are sufficient to use the sharpened long sides of the sampling space through this movement control to completely pull the tissue into the sampling space even with hard tissue samples by separating the tissue lying on the side, thereby achieving an improved degree of filling in the sampling space. After this shaking motion of the biopsy needle, the gear motor 21 reversed and the sampling room 39 is closed by turning the cutting sleeve, the cutting edge 72 the cutting sleeve 3 the tissue is cut off during the closing process. It goes without saying that, by means of appropriate design modifications or corresponding controls and additional electrical elements, the shaking movement for separating the lateral test edges can also take place while the cutting sleeve is being opened. During the closing process, the cutting sleeve is also advanced beyond its closed position, approx. 2 mm, in the direction of the needle tip. This will certainly cut the fabric fibers. The cutting sleeve is then moved back by 2 mm to the closed position. It is controlled by the microprocessor, in which the setpoints are stored and which the microprocessor compares with the measurement data (counting data) and thus controls the processes. Due to the special design of the sampling space and due to the vacuum applied, the tissue sample is held in the sampling space in a rotationally secured manner, so that the cutting sleeve, which is outside and rotates longitudinally displaceably, surrounds the biopsy needle 3 the tissue sample is not twisted or twisted as described. After the sampling space is closed, the DC gear motor for the vacuum generating unit 5 activated. The piston 54 is first retracted until the piston clears the ventilation hole ( 11c ). After the vacuum in the system has been released, the plunger moves so far to the syringe base that the ventilation hole is closed again in order to prevent the outflow of body fluid (cytological fluid). This brief opening of the ventilation hole is in the range of a fraction of a second to prevent liquid from escaping. The flashing of the sampling diode 92 goes out. The ejection diode 93 lights up yellow. The biopsy needle with the closed sample room is pulled out of the cannula.

d) Taking the sample after the biopsy needle is removed from the tissue

After removing the biopsy unit and providing a vessel for holding the tissue sample and liquid, the program key 89 actuated again and the ejection diode 93 be starts blinking. Due to the delay switching for safety reasons, the program button must be pressed for approx. 1.2-1.5 seconds before the process is initiated. First, the gear motor 21 the cutting sleeve is actuated to open the sampling space about halfway. After that, the DC gear motor 58 the vacuum / pressure generating device activated. The direction of rotation of the DC geared motor 58 remains and the lead screw 53 with the piston moves towards the syringe base, so that an overpressure is created in the system. The piston is moved up to the piston crown, the drive motor 58 is deactivated. The gear motor 21 moves the cutting sleeve back over the sampling space after the piston has reached the piston crown. As a result of the overpressure built up in the system, the sample is pressed under pressure into a ready-to-use laboratory vessel while 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 plug narrowing the biopsy needle cavity 79 , which has made it difficult or impossible for tissue to penetrate 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 yellow. If no further sample is to be taken, the housing cover is opened and the removable element 20 away. When opening the housing cover 10 the system is via the microswitch 18 disabled. However, if another sample is to be taken from the same tissue environment, the operator presses the program key 89 and the reset diode 91 starts to flash. The basic setting of the vacuum / pressure generating device, such as the cutting sleeve, takes place again as described. After the process is complete, the reset diode goes out 91 and the sampling diode (green) and the voltage diode yellow) light up. It is again up to the operator whether he just wants to cut another tissue sample out of the same bullet hole - in this case he presses the program button 89 - or whether he wants another shot by tensioning the biopsy needle - in this case he presses the tension button 90 , Depending on the choice, the further 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 sampling area after the injection, for example to the side of it, the location of the sampling area can be changed 71 via the knurled screw 80 be twisted. A mark in the form of a notch is on the knurled wheel so that the operator can recognize this radial position of the sampling space 119 attached, which points upwards when the opening of the sampling space points upwards. In the set position, the biopsy needle is pushed through the faces of the polygon 50 and fixes the elastic forces in the carrier part. The sampling procedure is the same as described above.

After the end of the biopsy, the interchangeable element becomes after unlocking the lid 20 (Vacuum / pressure device, biopsy needle / cutting device with all elements arranged on it) removed upwards. A safety wing is attached to the biopsy needle carrier to make it impossible to open the housing when the tensioning slide is tensioned 84 arranged in the tensioned state on the left face 85 the closure device is present. As a result, the locking device, which can be moved in the X axis, can no longer be moved to the left in the open position and the nose can thus 12 no longer out of the recess 45 be taken out. 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 area 85 of the bolt abuts the security wing. The battery charging diode 96 is switched off as soon as the housing cover is opened. With the lid closed and the insert element inserted 20 the battery charging diode indicates whether there is sufficient energy.

Basically, it is conceivable that all steps for taking a sample and tensioning the slide, etc. Activation and deactivation of the two geared motors individually by Be controlled by hand. However, it is advisable to take individual steps of the process are summarized and run automatically and only the initiation of the next step by operating the switch in Gear is set. This semi-automatic method, as previously described, has proven to be particularly advantageous.

There are basically two methods for recording the actual values for comparison with the Target values conceivable. 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 record these changes, photocells or microswitches must be installed inside the housing, especially on the extension of the base block 8th , arranged. When measuring the change in conjunction with a photocell, there is also a positioning finger on the cutting sleeve 103 attached, while in the threaded spindle of the vacuum / pressure generating device the free end protruding from the piston unit 61 can be used as a measuring point. If the front edge of the biopsy needle holder is used as a measuring point with a photo cell, no additional positioning finger is required. The embedded photo cells are covered with a suitable, transparent material due to possible contamination. The positioning finger 103 passes through a slit in the biopsy needle holder. At the appropriate points, on the extension 46 of the base block 8th are recesses 107 provided, in which photocells or microswitches are installed, either with the free end 61 the piston spindle, with the position finger or the biopsy needle carrier edge 120 interact ( 15 ). These signals (actual value) are processed in the electronics and form the control signals.

The other system is based on the measurement of the number of revolutions of the DC geared motors, which have been converted into units of length, which is particularly expedient if the changes are carried out by means of the geared 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 donor exists (cf. 3 ) from a two-armed impeller 131 and a photocell connected to the motor. These encoders on the two drive motors supply the counting pulses for the photocells, which they pass on to the programmable microprocessor, which compares these data with the previously stored specifications and thereby triggers the control pulses. 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 significantly reduces the number of revolutions, precise longitudinal control is possible in this way. The longitudinal displacement by the spindle drives is always an equal amount proportional to the number of output revolutions and the number of revolutions is therefore sufficient as a control signal for the accuracy of the longitudinal displacement. To the position of the cutting sleeve 3 as well as the piston 54 at the beginning, i.e. after inserting the removable element and closing the housing cover 10 the DC geared motor rotates precisely 58 the piston 54 abuts on the syringe base and the DC gear motor 21 brings the cutting sleeve drive to zero position by the gear 74 on the threaded nut 75 to the stop (the threaded nut 75 runs on the gear 74 on). 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 (room 39 ).

1

handpiece

2

biopsy needle

3

cutting sleeve

4

connecting element

5

Vacuum / pressure

generating device

6

Gehäuseenddeckel (Left}

7

Gehäuseenddeckel (right)

8th

basic block

9

Housing bottom

10

housing cover

11

locking latch

12

nose

13

Durchfühnng

14

drilling

15

execution

16

execution

17

spigot

18

microswitch

19

switch Probe

20

removable element

21

Gleichstromgetriebebemotor

22

wall

23

toothed roller

24

U-shaped room

25

wall

26

block

27

groove

28

clamping slide

29

threaded hole

30

bolt

31

spiral spring

32

tail

33

double lever

34

compression spring

35

axis

36

bracket

37

Biopsy needle carrier

38

drilling

39

40

tabs

41

Surface slide carriage

42

renewal the area

43

sliding surface

44

Area of Blocks 26

45

recess

46

cover

47

Plastic part

48

Threaded spindle nut

49

bearing element

50

polyhedron

51

syringe ground

52

syringe body

53

screw

54

piston

55

gear (Ring gear)

56

pinion

57

Control panel

58

DC gear motor

59

transverse plate

60

surfaces

61

free The End

62

insertion element

63

Support

64

outflow fitting

65

recess

66

chamfer

67

ventilation opening

68

cutting edge

69

Piston-cylinder unit

70

pinpoint

71

Sampling room

72

cutting edge

73

Threaded spindle sleeve

74

gear

75

Threaded spindle nut

76

sealing element

77

recesses

78

Plastic disc

79

Plug

80

thumbwheel

81

leadership

82

recess

83

metal part

84

safety catch

85

face

86

87

midrib

88

actuating button

89

program button

90

tension button

91

reset diode

92

Sampling diode

93

ejection diode

94

clamping diode

95

interlock diode

96

Battery charging diode

97

execution

98

execution

99

poor of the double-armed lever

100

part of the lever

101

flanks the leadership role Left

102

flanks the leadership role right

103

position finger

104

axis

105

driving device (Vacuum)

106

driving device (Biopsy

needle, Tensioning device)

107

recesses

108

tabs

109

insertion aid

110

pen

111

Aku

112

Plastic part

113

area

114

separating plate

115

guide bore

116

117

holding pieces

118

119

score

120

Needle carrier edge

121

washer

122

lip

123

Federation

124

short spiral spring

125

washer

126

pipe section

127

Federation

128

distal Hole in the sled

129

proximal side Drilling in

block 26

130

photocell

131

impeller

Claims (12)

Biopsy device consisting of a handpiece with drive elements into which a biopsy needle is inserted, part of the part of the biopsy needle protruding beyond the handpiece with its sampling space being insertable into the tissue to be examined and the tissue sample to be examined penetrating into the opening of the sampling space by means of negative pressure and then separated by means of a longitudinally movable sample separating device and in a further step the sample is taken from the sampling space, characterized in that the biopsy needle is moved briefly, slightly, several times back and forth ( 2 ) during and / or after opening the sampling room ( 71 ) the long sides of the sampling space support a lateral separation of the tissue due to the negative pressure created in the biopsy needle and only then is the sample completely removed by actuating the separation device. Biopsy device according to claim 1, characterized in that the two longitudinal side edges of the sampling space ( 71 ) with cutting ( 68 ) are provided. Biopsy device according to claim 1, characterized in that the cutting effect in relation to the cutting edge by an external pressure, e.g. from the ultrasound head or another compression device going out, amplified becomes. Biopsy device according to claim 1, characterized in that the cutting edges ( 68 ) are formed on the long sides of the sampling space in such a way that the inner radius (ri) of the sampling space changes into the outer radius (ra) by removing the material (T1) from the wall thickness and that the cutting edges are arranged in the area above 180 ° ( 11g ). Biopsy device according to claim 1, characterized in that the hub for moving back and forth is adjustable by programming the microprocessor. Biopsy device according to claim 5, characterized in that that the stroke is 2 mm. Biopsy device according to one or more of the preceding claims, characterized in that the forward or backward movement is generated in that the controlled drive motor for the needle / cutting device the clamping slide ( 28 ) against one between the block ( 26 ) and the tension slide ( 28 ) arranged short coil spring ( 124 ) pulls and then by reversing the motor ( 21 ) the spring supports the return of the tension slide. Biopsy device according to claim 6, characterized in that the forward / backward movement 5 is repeated at short intervals. Biopsy device according to claim 7, characterized in that that the control of the drive motor by one on the motor mounted encoder, which sends the signals to the programmable Microprocessor forwards. Biopsy device according to one or more of the preceding claims, characterized in that the drive, which consists of a piston-cylinder unit ( 69 ) existing vacuum / pressure generating device ( 5 ), which is arranged parallel to the biopsy needle carrier, and the drive of the biopsy needle / cutting device including tensioning device each consists of a gear motor, the direction and duration of rotation of which are controlled by a programmable microprocessor and the encoder for the respective measured values is arranged directly on the respective drive motor. Biopsy device according to claim 10, characterized in that triggering the program steps "clamping" and "expectoration the sample "about delay circuits be retrieved. Biopsy device according to one or more of the preceding claims, characterized in that during the closing process of the cutting sleeve for cutting out the sample, the cutting sleeve ( 3 ) is moved approx. 2 mm beyond the closed position in the direction of the needle tip and then moved back to the closed position by the same distance.