DE20204363U1 - biopsy device - Google Patents

Description

Biopsy device for taking tissue samples under vacuum.

The invention relates to a biopsy device consisting of a handpiece into which a hollow biopsy needle is inserted, wherein a part of the part of the biopsy needle protruding beyond the handpiece can be inserted with its sampling chamber into the tissue to be examined and the tissue is sucked into the sampling chamber by means of a vacuum and then separated by means of a sample separation device and then removed.

&iacgr;&ogr; GB 2018601A already discloses a method and device for cutting out tissue, in which the tissue in the biopsy needle is sucked into a cutting area under the influence of a vacuum. In order to generate a vacuum in the hollow needle, the handpiece, into which the hollow needle is integrated, is connected via lines to a vacuum generator arranged outside the handpiece. The sample is cut off using a cutting device that is arranged so that it can move longitudinally in the hollow needle. The cut-out sample is stored in the needle. After the needle is pulled out of the tissue, the cut-out sample is rinsed out of the needle tip; for this reason, the handpiece is connected via further lines to devices located outside the handpiece. The vacuum created in the hollow needle is regulated by control elements integrated into the lines.

EP 0890 339 A1 discloses another biopsy device in which the sample is taken under the influence of a vacuum. In the handpiece, in which the biopsy needle with cutting device is integrated and inserted, the biopsy needle is connected to an external vacuum generator and control devices via hose connections and lines. The vacuum is fed to the sample removal chamber from below via a channel formed on the outer sleeve of the biopsy needle. The separating device is arranged in the hollow space of the biopsy needle so that it can be moved longitudinally. The separating device cuts the sample from the tissue by means of a rotating movement combined with a manual longitudinal push. The sample is transported in the hollow channel of the separating device. A similar arrangement is also shown in US-PS 5526 822, in which in particular various vacuum feeds are used.

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to the sampling chamber, as the arrangement for cutting devices, in the hollow needle or coaxially as a cutting sleeve, outside are known.

In the known biopsy devices that allow sampling under vacuum, the handpiece of the biopsy device is restricted in its freedom of movement by at least one connecting tube and/or supply cable with one or more external supply units; in addition, the devices for generating vacuum are complex, in particular with regard to
the control devices. The sample is cut out by rotating cutting devices that move longitudinally in the needle cavity. Various drive devices are also used

The invention is based on the object of designing the handpiece in such a way that the sampling process can be controlled with one hand after insertion into the coaxial cannula. Furthermore, the vacuum generating device should be simple, reliable and uncomplicated in its construction and operation; the sampling should be carried out in such a way that the pathologist has a non-twisted sample for assessment.

The solution according to the invention consists in that the vacuum generating device is used to eject the sample, to generate an overpressure, the vacuum/pressure generating device and other control and supply devices are integrated into the housing of the handpiece, and the connecting element from the biopsy needle to the vacuum/pressure generating unit is arranged directly on the housing, the vacuum/pressure generating device consists of a controllable piston/cylinder unit which has a ventilation hole, that all drives are electrically operated and that the drive for the clamping slide is also used as a drive for the cutting sleeve, that the biopsy hole is surrounded by an external coaxial cutting sleeve and at the transition from the biopsy hole to the sample removal space a plug is arranged which projects from above into the cross-section of the biopsy hole and significantly narrows the cross-section, and that on the front side of the housing a

o5 Circuit board for the operation of the electronics integrated in the housing, into which the de-latching of the clamping slide is integrated.

The arrangement of all the necessary devices in the handpiece means that the handpiece can move freely; in addition, only electric drives are used, and the same drive is used to drive the clamping slide and the sample cutting device. This measure means that the drives can be housed in a relatively small housing. Even the electronics and the operating and control instruments are arranged on the housing or housed in it. This also applies to the power supply and the connecting elements. This makes it possible to combine sub-processes into one control step and to carry out the operation with one hand.

In order to make the vacuum generation device particularly simple and reliable, the use of a piston-cylinder unit with ventilation options has proven to be particularly advantageous for generating the vacuum and the overpressure.

This involves the use of a known syringe/piston unit with an additional ventilation hole in the upper part of the syringe body, which is opened to reduce the vacuum by further pulling back the syringe piston. By controlling the spindle drive of the piston spindle, the same piston/syringe unit can be switched from generating a vacuum to generating an overpressure as required, whereby a hole in the upper part serves to reduce the vacuum, through which air flows in and is subsequently compressed.

In order to be able to control the movement of the piston, particularly with regard to the changeover from building up a vacuum to releasing a vacuum and generating overpressure, a spindle drive with an electric DC motor with a downstream reduction gear has proven to be advantageous because the measured number of revolutions of the motor is a direct measure of the longitudinal displacement of the piston. Since it is a high-speed DC motor whose output speed is significantly reduced by a reduction gear, the longitudinal movement of the spindle can be precisely controlled. The length of the spindle travel and thus the size of the vacuum and the overpressure can be specified using corresponding target values in the control electronics, e.g. the number of revolutions of the motor.

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loo Since a sterile biopsy needle is used for each patient, it has proven advantageous to separate sterile parts from other, merely disinfected parts that are firmly connected to the handpiece. For this reason, it is advantageous to design the vacuum/pressure generating device, the biopsy needle with cutting sleeve and the parts connected to the biopsy needle and cutting sleeve, such as the biopsy needle carrier, drive elements and plastic part including connecting element and guide roller, as an independent, easily insertable and removable sterile insert element. The space for the insert element is separated from the other drive elements by covers for cleaning reasons.
For simplicity, the flexible connecting element is referred to as a flexible hose

no so that it can adapt to the displacement paths of the clamping slide. In order to be able to rotate the tube relative to the biopsy needle at the proximal end, an additional, pivot-mounted plastic part is arranged in the plastic part firmly connected to the biopsy needle, to which the tube is attached.
In order to enable the gear wheel connected to the spindle sleeve to move longitudinally, e.g. when releasing the clamping slide, a toothed roller is provided as a drive.

In order to tighten the clamping slide via the biopsy needle carrier by turning the cutting sleeve, the front gear on the threaded spindle sleeve is supported on a bracket of the base block during tightening so that the biopsy needle carrier is moved to the right while the cutting sleeve maintains its position.

The locking mechanism of the clamping slide has a double-armed lever, one arm of which engages under spring pressure in the recess of the clamping slide. In order to be able to use the clamping device for different biopsy needles with different insertion depths, e.g. from 15-25 mm, it is only necessary to adjust the locking lever length and a corresponding setting in the electronics.
The plastic part attached to the biopsy needle allows the sample collection chamber to be rotated using a knurled disk. The interaction of the polygon of the plastic part with the biopsy needle holder allows the biopsy needle to be rotated in the desired

no Position can be locked. A notch on the knurled disk shows the operator in which radial position the opening of the sampling chamber is located.

The cross-section of the biopsy needle is limited to the sampling chamber by a constriction, a stopper or a lip. This constriction is approximately 60-75% of the height and covers the upper, open part of the sampling chamber from above. This constriction in front of the sampling chamber means that the vacuum from the bottom - when the sampling chamber is opened - (i.e. when the cutting sleeve is retracted) sucks in the tissue to be examined. The constriction prevents

ho additionally prevents tissue from penetrating the rear part of the needle cavity. When the sample is ejected, the constriction causes an increase in pressure in the sampling chamber, which improves the cleaning effect, particularly in the sampling chamber. By applying the vacuum, the tissue of the sample is sucked into the interior of the sampling chamber and adheres to the inner wall. Additional means can be provided in the interior of the sampling chamber to improve adhesion. Since the cutting sleeve is arranged on the outer diameter of the biopsy needle and the tissue is thus separated on the outside, the tissue adhering to the interior is not detached from the inner wall by the cutting device due to the external arrangement of the cutting sleeve.

Furthermore, the tissue cannot penetrate into the cavity of the rotating cutting device and adhere to it. The guidance of the round-section cutting sleeve on the outside of the round-section biopsy needle has the advantage that the sample is not twisted by the cutting rotation of the cutting device, thus fulfilling an essential requirement for the pathologist's assessment of the tissue. In order to ensure that the sample adheres well to the interior without affecting the degree of filling, the sampling chamber is designed in such a way that approx. 25% of the sampling chamber cross-section is open for the sample to be sucked in, i.e. the larger part of the circumference is closed.

The external arrangement of the coaxial cutting sleeve also means that a larger sample can be taken than if the cutting sleeve is arranged on the inside.

Since the sample is ejected from the sampling chamber under pressure, no damage to the tissue occurs.

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The central arrangement of the base block in the center of the housing interior relieves the housing itself of transverse forces caused by the drive elements. In addition, the drives and the clamping slide are easy to replace, as only the connections to the housing need to be loosened. Another advantage is that the shocks caused by the plastic clamping slide are absorbed by the base block.

Storing the biopsy needle/cutting sleeve in a plastic biopsy needle carrier has the advantage, among other things, that the molded sliding surfaces enable trouble-free sliding on the mating surfaces of the base block and the molded block. The biopsy needle carrier transfers the forces from the spindle drive of the cutting sleeve to the clamping slide. Since the spindle drive is supported on the holder of the base block when the clamping slide is adjusted and can slide freely when the clamping sleeve is rotated (the gear can slide axially in the toothed roller), the drive can be used for both movement processes (clamping the clamping slide, opening and closing the sample extraction chamber using the cutting sleeve). The microswitch integrated in the end section of the housing, which switches the power supply on and off when the housing cover is closed when the vacuum/pressure generation device is inserted, and the safety wing attached to the biopsy needle carrier are safety devices that prevent the clamping slide from being clamped when the housing cover is open. In addition, opening the housing cover with the needle tensioned should be prevented.
The guide roller, which is housed in the housing end cap and penetrated by the biopsy needle with cutting sleeve, interacts with the cannula that was previously inserted into the tissue. As a sealing element that interacts with the cutting sleeve is placed on the proximal end of the previously placed coaxial cannula, this prevents air from penetrating between the cannula and the cutting sleeve. The guide roller placed on the cannula prevents the inner housing from becoming dirty and the non-sterile handpiece from touching the coaxial cannula. The circuit board on the handpiece with integrated LEDs and switches as well as pictograms ensures simple operator guidance.

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The cover plate can also be used as a carrier for microswitches or photocells.
The insertion aid makes it easier to insert the sterilized replacement element.

An example of an embodiment is described in more detail below using drawings. It shows:

Fig. 1 Biopsy device with opened housing cover (perspective)

Fig. 2 Housing-mounted unit of the biopsy device (without housing base and

Lid) and exchangeable biopsy unit !(perspective) shown separately

Fig. 3 Longitudinal section A - A through the biopsy needle in Fig.1

Fig. 4 Cross section B - B in Fig. 1 (left housing part)

Fig. 5 Cross section C - C in Fig. 1 (right housing part)

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

Fig. 7 Front of board

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

Fig. 8b Base block in X-axis seen from behind (perspective)

Fig. 9a Housing-fixed units of the biopsy device without housing cover and base in the unclamped state

Fig. 9b Locking device in the unclamped state

Fig. 10a As Fig. 9, but clamping slide in clamped position

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

Fig. 11a Biopsy needle spitee side view

Fig. 11 b Longitudinal section through Fig. 11a (sampling chamber opened)

Fig. 11c As Fig. 11b, but (sampling chamber half open)

Fig. 11d As Fig. 11 b (sampling chamber closed by cutting sleeve)

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°, perspective)

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

Fig. 14a Vacuum pressure device with piston placed on the syringe bottom (initial position for vacuum generation and final position for

Pressure generation, partially cut open)

Fig. 14b Vacuum pressure device with retracted piston; end position of the vacuum stroke (partially cut away)

Fig. 14c Release of the ventilation hole; (syringe plunger retracted over ventilation hole; pressure equalization position, partially cut open)

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

Fig. 15 Base block and biopsy needle/cutting sleeve, prepared for fitting with photocells and microswitch for actual value detection

Fig. 16 Insert element lifted from the insertion aid (perspective)

Fig. 17 Insertion aid (perspective)

All devices required for performing a vacuum biopsy are integrated in the housing interior of a handpiece 1 (Fig. 1), so that no cables or lines are required from the housing of the handpiece to other external supply devices. The handpiece 1 thus represents a complete

\ Vacuum biopsy device that 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, which is required for taking the tissue sample. Usually, a coaxial cannula is placed in the tissue, into which the biopsy needle 2 with cutting sleeve 3 is inserted. A connecting element 4 is guided outside the right housing end cover 7, e.g. a transparent, flexible tube that connects the vacuum/pressure generating device 5 arranged parallel to the biopsy needle with 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 other elements arranged in a biopsy needle carrier 37 forms with the connecting element 4 and the

>285 Vacuum/pressure generating device 5 has an element 20 that can be easily removed upwards and inserted and is changed as required (Fig. 2). To do this, the housing cover 10 is opened. As shown in particular in Fig. 2, the biopsy device can be divided into parts that are firmly connected to the housing (disinfected parts) and a removable element 20 (sterile part). While the parts firmly connected to the housing are only disinfected, the removable element 20 is delivered sterilely packaged and replaced as required, especially for each new patient.

In the embodiment described below, the vacuum/pressure generating device is arranged parallel to the biopsy needle. Within the scope of the invention, however, the vacuum/pressure generating device can also be arranged lying in the axis of the biopsy needle or the handpiece; there is also no need for

its own connecting element, for example if it is placed directly on the end of the biopsy needle.

Between the left and right housing end covers 6, 7 there is a housing base 9 and a housing cover 10 pivotably mounted in the housing end covers with a locking latch 11. The housing base 9 is clamped between the housing end covers 6, 7 or connected to the base block δ by means of tie rods or screws, which are partially screwed into a base block δ. The housing cover 10 is pivotally connected via an axis fixed in the housing end covers 6, 7. The housing cover 10 is

' of the biopsy device is closed; the inner contour of the housing cover corresponds to the outer contour of the biopsy needle carrier 37, which will be described in more detail later. The base block δ is arranged approximately in the center of the housing interior and is firmly connected to the lower part of the housing, e.g. via fixing elements and/or via a screw connection. The drive elements for the vacuum/pressure generating device 5, the cutting sleeve 3 and the clamping device for the clamping slide 28 on which the biopsy needle carrier 37 is placed are connected to 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 base block 8 also has a holder 36, which is open at the top, for the biopsy needle/cutting sleeve and a further insert element 62 for the vacuum/pressure generating device.

To describe the position of the individual elements and the position of the individual parts, particularly in the housing interior, a coordinate cross has been drawn in Fig. 1, with the coordinate center of the coordinate system in the center of the base block 8 (Fig. 1). Accordingly, for the following description and for the claims, the direction information is considered to be left (distal) in the direction of the X-axis and right (proximal) in the opposite direction to the X-axis. For the other coordinates, the direction of the Y-axis is considered to be top, the opposite direction to the Y-axis is considered to be bottom, the direction of the Z-axis is considered to be back and the opposite direction to the Z-axis is considered to be front (Fig. 1). The coordinate system divides the housing interior and the other references into left and right, front and back, and top and bottom.
With reference to these specifications, the common drive devices 106 for

the clamping device and the cutting sleeve and in the lower, rear, left-hand part of the housing the drive device 105 (Fig. 13) for the vacuum/pressure generating device 5. The power supply for the drive motors and the other electrical equipment, such as for the control and/or monitoring elements, is housed in the lower, right-hand part; batteries or a rechargeable battery 111, e.g. a 7.2V lithium-ion battery, 1Ah, are preferably used for this. The front, right-hand, upper housing interior, located above the battery compartment, is used largely for the clamping 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 there 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 clamping slide 28, in which the

Biopsy needle/cutting sleeve unit with drive parts is rotatably mounted, which extends over almost the entire length of the handpiece. The biopsy needle carrier can be moved lengthwise using the clamping slide, as described later. This means that when not clamped, the left front surface of the biopsy needle carrier 37 rests on the left housing end cover 6, and when clamped, the right front surface rests on the right housing end cover 7. "Almost the entire length" means that the biopsy needle carrier is at least shorter by the amount that the housing interior is required for the clamping process. If the clamping path of the clamping slide is 20 mm, for example, the biopsy needle carrier must be able to be moved by this amount. In general, the clamping path is between 15 and 25 mm, depending on the biopsy needle used. It is therefore advisable to design the interior for the greatest possible clamping path.

The clamping device (right, at the front) itself consists of a clamping slide 28 guided on a bolt 30, whereby the bolt can be screwed into the base block 8. The bolt 30 is surrounded by a spiral spring 31. The locking device (see in particular Fig. 9b and 10b) of the clamping slide is attached to the block 26. The vacuum/pressure generating device 5 with parts of the drive is housed in the upper, rear, right-hand housing interior; the

The drive motor with reduction gear for the vacuum/pressure generating device is located in the left, lower, rear area of the housing interior.

The handpiece and in particular the biopsy needle or the vacuum/pressure generation device are not connected to additional supply units located outside the housing handpiece via cables or hoses. Mobility and maneuverability are therefore not restricted by lines or cables.
The housing cover, the housing base, the housing end covers and the base block are preferably made of aluminum.

The handpiece 1 consists, as already described, of a housing which is made up of a housing base 9 with walls raised to different heights on the sides, a housing cover 10 adapted to the housing base with a longitudinally movable locking latch 11 and the two housing end covers 6 and 7. The housing base is connected to the two housing end covers via tie rods or screws, e.g. made of iron, some of which are 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 x 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 latch 11 can be pushed into the recess 45 of the base block δ to close the housing cover. The left housing end cover 6 has in the upper, front part a U-shaped passage 13 which is open at the top for the part of the biopsy needle/cutting sleeve 2, 3 which projects forwards and the guide roller 81 arranged thereon. The rear housing end cover 7 has two U-shaped passages 15, 16 which are open at the top. The passage 15 corresponds to the passage 13; it receives the end of the round cross-section plastic part 47 which is placed on the hollow biopsy needle. A nozzle 63 of the vacuum/pressure generating device is inserted into the passage 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 nozzle 64 of the vacuum/pressure generating device. The inner cavity of the biopsy needle is connected to the cavity of the piston/cylinder arrangement and the cavity of the vacuum/pressure generating device via the hollow connecting element 4.

The connections are designed in such a way that neither air can penetrate into the system from the outside nor can air escape to the outside in the event of excess pressure; the connection points are therefore airtight. As shown in particular in Fig. 6, a microswitch 18 is integrated into the feedthrough (16) of the housing end cover 7 on the lower side, the switching pin 19 of which projects into the feedthrough.

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

^405 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 attached to the housing is designed as a separate component, which is glued, for example, to the surface 113 of the lower housing part 9. This circuit board 57 is connected via cables to other electronic components arranged in the housing and to the power supply. The circuit board mainly contains switches for operating and diodes for control. The actuating button 88 for the mechanical release of the tensioned tensioning slide 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 ensure that there is no gap between the clamping process of the clamping slide and the release of the

' clamping slide on the one hand, and on the other hand, the execution of the biopsy, such as the removal of the sample and the taking of the sample with the ejection of the sample. Accordingly, the actuation button 88 (trigger) for the clamping slide is placed to the right and the clamping button 90, which triggers the clamping of the clamping slide, is placed to the left. The program button 89, intended for carrying out the biopsy, is in the middle. Pressing the program button is required for three functions. The first function, start or repetition (reset), is indicated by the reset diode 91, the sampling diode 92 arranged below it indicates the opening and closing of the sampling chamber during the sampling. The lowest ejection diode 93 indicates the ejection of the sample taken. The clamping diode 94 indicates the clamping of the clamping slide; the locking diode 95 indicates the locking of the clamping slide. The battery charging diode 96 indicates the

Charge level of the battery or accumulators. The diodes are connected in such a way that when the called process is carried out, the diode flashes and when the process is completed, the diode of the subsequent process lights up. If two options are available, both subsequent diodes light up. The operator is then free to choose which one to choose. The operation and control options are discussed 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 6 (seen 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 is shown in Fig. 8b (both views in perspective). The base block 8 can be divided into two halves in the longitudinal direction; the front part is used to attach the common drive for the cutting sleeve and clamping slide and, in its upper part, to support the biopsy needle carrier (Fig. 8a); the rear part is used to attach 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 a U-shaped space 24 in its left, front part, in which a toothed roller 23, which is driven by the gear motor 21, is installed.

For this purpose, the output shaft of the gear motor is mounted or inserted in an opening in the wall 25 of the base block 8. The toothed roller 23 is placed on the output shaft and secured against rotation and displacement, e.g. by means of a screw.

&igr;. On the other side, the toothed roller 23 is mounted in the wall 22 of the base block 8. A direct current motor with a speed of approx. 11000 rpm is used as the drive motor. A planetary gear with a high reduction ratio is connected downstream of the direct current motor, and the toothed roller 23 is placed on the output shaft of this planetary gear.
Another block 26 is formed on the wall 22 pointing to the right, which accommodates the pivoting double lever 33 for locking, and also serves to attach the bolt 30 for guiding the clamping slide 28. The bolt 30 is screwed into the threaded hole 29. During the clamping process, the clamping slide 28 slides to the right on the bolt 30 and the separating plate 114 arranged underneath. During the clamping process, the spiral spring 31 arranged on the threaded bolt 30 is compressed. The spiral spring rests with one end on

an end piece 32 of the threaded bolt or directly on the housing end cover 7; the other end of the spiral spring rests on the end of the guide bore 115 of the clamping 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 locking device engages in a groove 27 of the clamping slide 28 (Fig. 9a and 10a). The locking 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 fastened in the holes 38 of the base block. In the unclamped state, part 99 of the double-armed lever lies in the groove 27 of the clamping slide; the compressed spring 34 acts on part 100 of the lever to press the locking button 88 outwards (forwards). As soon as the part 99 of the double-armed lever can engage in the recess 82 of the clamping slide, the actuating button 88 is pressed outwards. The clamping slide is locked in the clamped state by engaging the lever part 99 and can now be released if required using the actuating button 88. Since the clamping slide is conveniently made of plastic, it has proven to be useful to insert a metal part 83 into the recess 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 renewed insert element can be used multiple times.

The clamping path corresponds to the depth of penetration of the biopsy needle into the tissue. This means that the length of the lever 99 also corresponds to the clamping path. Since the penetration depths are usually 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 settings in the control accordingly.

The clamping slide 28 adjoining the block 26 is arranged at the same height and has approximately the same cross-section. On its upper side, the clamping slide has two tabs 40. The upward-facing surface 41 of the clamping slide, as well as the upward-facing surface 44 of the block 26, as well as 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 carrier is made of plastic. When the clamping slide is moved from the unclamped initial state (Fig. 9a) to the clamped state (Fig. 10a), i.e. to the right, the biopsy needle carrier 37 held by the tabs 40 slides over the surfaces 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 easily and in a straight line on the sliding surface and that after the actuation button 88 is triggered, 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 to match the inner contour of the housing cover and has only a small amount of play with the housing cover in order to prevent the biopsy needle from moving 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 that is open at the top, for inserting the biopsy needle/cutting sleeve, among other things. This holder serves primarily as a radial thrust bearing, i.e. to support 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, another U-shaped insert element 62 is provided, into which the free end 61 of the threaded spindle of the vacuum/pressure generation device, which protrudes from the syringe body, is inserted. In the middle, top, of the base block, a fastening is provided for a plate that accommodates the recess 45, into which the nose 12 of the locking latch 11 of the housing cover is inserted. A cover 46 arranged on the base block 8, 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 to store the exchangeable biopsy needle carrier 37, including the biopsy needle and cutting sleeve. The cover 46 protects the electric gear motors and the circuit board from contamination. The circuit board for the electronics is located between the drive motors and below the central rib.

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

A threaded spindle sleeve 73 with a gear 74 arranged on the front side of the threaded spindle sleeve is attached to the other, proximal end of the cutting sleeve, facing away from the cutting edge 72. The threaded spindle sleeve with gear is arranged on the cutting sleeve in a way that prevents rotation and displacement. A threaded spindle nut 75 works together with the threaded spindle, which is firmly screwed into the biopsy needle carrier 37.

\ is pressed in. The gear 74 is on the left, i.e. in front of the start of the spindle sleeve. When the threaded spindle sleeve is rotated using the gear 74, the cutting sleeve is rotated and moved longitudinally over the biopsy line 2.

The gear 74 at the left end of the threaded spindle meshes with the toothed roller 23 after the biopsy needle carrier has been inserted into the tabs 40. In order to be able to insert the biopsy needle carrier 37 into the tabs of the clamping slide when the clamping slide is not clamped (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. On the left side of the gear, a

Plastic disk 78 must be inserted, which is provided with a slight cone. If the biopsy needle carrier is correctly inserted, the biopsy needle carrier slides with the sliding surface 43 over the surfaces 42 and 41 to the right when the clamping slide is tightened. Since the sample extraction chamber is closed first after the biopsy needle carrier is inserted, the gear 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 clamping slide to the right via the biopsy needle carrier until it is locked; the biopsy needle is thereby drawn inwards, while the cutting sleeve remains in its position. After locking, the cutting sleeve protrudes beyond the biopsy needle tip. Therefore, after the clamping slide is locked, the cutting sleeve is rotated back to its starting position (opposite direction of rotation); the gear 74 moves from left to right in the toothed roller. After the clamping slide has been released, the biopsy needle holder and the biopsy needle/cutting sleeve with gear slide back to the left. The cutting sleeve can now be moved back to the right to open the sample collection chamber.

The right end of the cutting sleeve is connected to the hollow biopsy needle via a sealing element 76 in a rotationally movable but air-tight manner so that neither air can penetrate between the biopsy needle and the cutting sleeve coaxially surrounding it, nor can air escape in the event of excess pressure. A

> 580 round, also hollow plastic part 47 is placed airtight and connected to the biopsy needle in a force-locking manner. The plastic part 47 has a bearing element 49 on its left end, which is pressed into the biopsy needle carrier; on its right end, which protrudes from the handpiece, another plastic part 112 is inserted, which can rotate relative to the plastic part 47 and relative to the biopsy needle 2. An O-ring is inserted between the biopsy needle and the plastic part 112 for sealing. The plastic part has a pin 17 on its right end, onto which the connecting element 4 is pushed airtight. Also on the right part, which protrudes from the biopsy needle carrier and the housing, there is a knurled disk 80, with which the position of the sampling chamber can be radially adjusted by turning, without changing the position of the cutting sleeve. By turning the biopsy needle, only the rotation of the

sampling chamber and thus the sampling device. The plastic part 47 with 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 mounted in the biopsy needle carrier and in the cutting sleeve via the bearing element 49 and its tight guide in the cutting sleeve and can be moved along the longitudinal axis with the biopsy needle carrier. As previously described, the cutting sleeve can be moved axially 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 locked to the biopsy needle carrier by clamping, so that the sampling area of the biopsy needle can be brought into the most favorable position for biopsy sampling and held by means of the knurled disk 80.
Details of the sampling chamber and the biopsy needle tip are shown in Fig. 11a - 11e. The sampling chamber 71 adjoining the needle tip 70 is open at the top for approximately 25% of its cross-section. The sampling chamber is approximately between 15 and 25 mm long. The cavity of the biopsy needle is connected to this. At the transition, i.e. at the right end of the sampling chamber, the cavity cross-section of the biopsy needle is closed between 50% and 75% by a constriction, e.g. a plug 79 (Fig. 11b - 11e). The height of the plug is such that

&ogr;&iacgr;&ogr; is designed so that it extends downwards beyond the recess of the sampling chamber. The vacuum is intended to draw the tissue sample into the sampling chamber with the continuous opening of the sampling chamber and to

> Bring it into contact with the wall of the sampling chamber. If there is excess pressure in the biopsy needle cavity, the constriction, the plug, increases the pressure. The plug is approximately 10 mm long and is glued or welded into the cavity. Laser welding has shown that it is advantageous to make the left side of the plug thin by removing material from the front surface to a short length, approx. 2 mm. This means that the tube of the biopsy needle is welded through to the front side of the plug in this area on the front surface and is airtight on the front side. The plug can also be shorter in 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 mainly comes into effect from the bottom, so that the sample adheres to the wall of the sampling chamber during the cutting process and

their position does not change. It has also proven advantageous to provide additional fixation devices on the sample collection wall. By sucking the sample into the sample collection chamber from below, the sample collection chamber is filled to a high degree and, above all, its design ensures that the sample is well fixed to the wall. As the cutting sleeve cuts off the sample on the outside of the biopsy needle, the sample is suctioned onto the inside even during the cutting process. In addition, the vacuum created by the cutting sleeve on the outside means that no tissue is sucked into the hollow cutting sleeve, meaning that the tissue cannot be twisted or distorted by the rotating longitudinal movement of the cutting sleeve as it is held in the cutting sleeve interior. The quality of the sample is improved because the pathologist receives 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 stopper 79 also completely cleans the sampling chamber so that no mixing occurs if the sample is repeated. Since the vacuum generating device is also used as a pressure generating device, the entire cavity, especially the needle, is cleaned.

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

k 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, to the end of which facing the syringe base 51 a piston 54 with sealing elements - as is generally known for syringes - is attached (Fig. 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 spindle nut has one or more threads. The threaded spindle 53 interacts with the threaded spindle nut 48. The spindle has a pitch of approx. 5 mm per thread, so that with each revolution the piston is moved by the spindle drive by a precisely defined amount out of the syringe body, i.e. away from the syringe base 51, or towards the

The gear ring 55 arranged on the circumference of the threaded spindle nut meshes with the drive pinion 56, which is attached to the output shaft of the DC gear 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 towards the syringe base or towards 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 planetary gear with a high reduction ratio. It corresponds to the motor for the clamping device already described.

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

In order to prevent the threaded spindle 53 from twisting when the threaded spindle nut is driven, the two opposing surfaces 60 of the threaded spindle are flat (Fig. 14d). The threaded spindle is inserted into the insert element with its free end. The distance between the surfaces of the threaded spindle corresponds to the width of the U-shaped insert 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 spindle nut is supported on the base block.
In order to prevent the syringe body 52 from slipping out when the threaded spindle nut is turned, 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 in an approximately horizontal position.

In order to make the threaded spindle easy to turn, the threaded spindle nut with gear ring has a chamfer 66 of about 1.5 mm on the side facing the base block. In addition, since the surface of the rib 59 on the base block 8, which interacts with the chamfer 66 of the threaded spindle nut 48, is inclined from top to bottom, the vacuum/pressure generating device is pulled downwards during operation. To generate a sufficient vacuum of about 200 hph in the sampling chamber, for example with a biopsy needle length of about 250 mm and an inner diameter of the biopsy hollow needle of about 5 mm, a syringe body for

ti* * *

20 ml with a length of approx. 90 mm. In order to be able to use the syringe body as a pressure generator, a ventilation hole 67 of approx. 1.5 mm is provided after about ³ A of the length, corresponding to the stroke for generating the vacuum (position according to Fig. 11b). If the syringe piston is moved beyond the ventilation hole 67 (Fig. 14c),... - when the vacuum is no longer required - the previously built-up vacuum in the hollow biopsy needle is reduced by supplying air (atmospheric pressure) via the ventilation hole 67. If the direction of rotation of the gear motor is then reversed, the vacuum/pressure generating device in the system will build up an overpressure by moving the piston in (towards the syringe base), which will cause the ejection of the

&igr; tissue sample. In addition, the compressed air not only

Not only the sample collection chamber, but also the interior of the biopsy needle is cleaned. The plug that narrows the needle cavity makes it difficult or even completely impossible for tissue particles to penetrate the biopsy needle cavity. The narrowing of the needle cavity by the plug 79 increases the pressure in the sample collection chamber and thus improves the ejection of the sample, especially when the sample collection chamber is half open.

The operation of the biopsy device is explained in more detail below:
The removable insert element 20, consisting of vacuum

/Pressure generating device, elastic connecting element and

Biopsy needle carrier with needle and cutting sleeve and other associated

\ elements, as well as a guide roller 81 placed on the needle, is delivered in sterile packaging. The piston 54 in the syringe body 52 is slightly raised (1-2 mm) from the base of the syringe on delivery, the sampling chamber 71 of the biopsy needle 2 is open so that a visual inspection of the sampling chamber can be carried out prior to insertion. After opening the housing cover 10, the carrier element 37, including the biopsy needle 2, cutting device 3 and other connected parts, 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 to ensure that the gear 74 engages with 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 clamping slide are inserted into the recesses 77 of the carrier element; the leadership role 81 is in the

The vacuum/pressure generating device is then inserted into the feedthrough 13 so that the flanks 101 and 102 enclose the housing end cover 6. The cutting sleeve is mounted in the guide roller so that it can be moved lengthwise and rotate freely; however, the guide roller itself can no longer be moved relative to the cutting sleeve after it has been inserted into the housing end cover. The vacuum/pressure generating device is then inserted into the upwardly open insert element 62 of the base block 8 with the free end 61 and into the U-shaped, upwardly open feedthrough 16 with the nozzle 63. The nozzle 63 is located above the switching pin 19. Since the base block-side insert element has a clear width that just allows the threaded spindle, which has surfaces 60 on both sides, to be inserted, the threaded spindle is held in the insert element so that it cannot rotate. After insertion, the gear ring 55 of the threaded spindle nut 48 engages in 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 is kept such that the syringe body 52 with the threaded spindle nut 48 placed on the syringe body just fits. The unit of syringe body and attached gear is thus held in such a way that it cannot be moved axially. After insertion, the vacuum/pressure generation device lies parallel to the biopsy needle carrier; the connecting element describes an arc of approx. 180 °.

It should also be noted that the insertion takes place when the clamping slide is not tensioned; this means that the gear 74 engages the right-hand end of the toothed roller when the sampling chamber is open (Fig. 3). After correct insertion, the housing cover can be closed.
To make the insertion process easier, an insertion aid can be used. When closing the housing cover, the nozzle 63 is pressed downwards 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 flashing of the reset diode 91 on the front of the handpiece. The reset diode initially flashes green, which means that the positioning of the individual elements, i.e. the insertion process, is not yet complete; the DC gear motor 21 must first close the sampling chamber 71 with the cutting sleeve 3 (the sampling chamber 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 on the inside of the holder 36 comes to rest.

comes. The plastic disk 78 rests on the holder 36 (inside) after the sampling chamber has been closed. During this process or before or after, the DC gear motor 58 brings the syringe plunger 54 into contact with the syringe base 51. After the starting positions for the vacuum/pressure generation device and the biopsy needle/cutting sleeve have been reached, the clamping diode 94 and the sampling diode 92 light up green and the reset diode goes out. The operator must now decide whether he wants to initiate clamping of the clamping slide or take another sample, e.g. because he has already taken a tissue sample. If the operator presses the clamping button 90, the clamping of the clamping slide is initiated; the clamping diode flashes green and the sampling diode 92 goes out. When the clamping button is pressed, the electric DC gear motor 21 receives power and the DC 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 by the plastic disk 78 on the holder 36, 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 moving into the cutting sleeve. The biopsy needle carrier 37 is moved via the recess/tab connection of the

) clamping slide is moved to the right against the action of the spiral spring 31 until the lever 33 of the locking element is pressed into the recess 82 of the clamping slide by the spring 34. The clamping slide is locked in this position. The gear motor receives the control command that the locking position has been reached, e.g. via a photocell embedded in the sliding surface of the cover plate, which interacts 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 tip by moving the clamping slide and the biopsy needle. At the end of this step, the cutting sleeve closes the sampling chamber completely (Fig. 11 d), as at the beginning of the clamping process. The locking diode 95 lights up green; the flashing of the clamping diode 94 goes out. In order for the friction force between the gear and

The plastic disk 78 is arranged between the gear 74 and the holder 36 in order to reduce the force of the support element. The biopsy needle of the biopsy device is now inserted, for example, into a previously inserted coaxial cannula. The proximal end of the inserted coaxial cannula contains a seal which is dimensioned in such a way 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 cutting sleeve to be easily inserted. The sealing ring prevents air from being sucked in from the 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 introduced or shot in. This virtually eliminates the possibility of contamination of the disinfected handpiece; 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 guided to the tumor in the cannula and, after correct positioning, is injected into the tumor.
The shot is fired by pressing the actuation button 88. Pressing this button results in the clamping slide being released by pivoting the double-armed lever 33 around the axis 35. The clamping slide is thrown to the left by spring action. The sampling diode lights up green, the clamping diode goes out. The sampling sequence is released by pressing the program button 89; the sampling diode 92 flashes green. First, the DC gear motor 58 of the vacuum/pressure generating device is activated. The

The piston of the vacuum/pressure generating device is moved in the direction of the base block, i.e. away from the syringe base, until it reaches a position shortly before the ventilation hole 67 is opened (Fig. 14b). The vacuum in the system is generated. After reaching its end position, the system activates the motor 21, the cutting sleeve which closes the sampling chamber is opened via the gear/spindle drive. During the opening process, the negative pressure prevailing in the system sucks the tissue and any cytological fluid (cytological material) into the sampling chamber one after the other. Cytological fluid will also flow into the biopsy needle cavity and into the vacuum/pressure generating device due to the vacuum. It has proven to be advantageous that the negative pressure is directed primarily to the lower area, the lower side, of the sampling chamber by the stopper (79), and that the stopper 79 prevents penetration of the cytological fluid into the biopsy needle cavity.

of the tissue into the hollow biopsy needle is made more difficult or even prevented. If the sampling chamber is completely open - the tissue sample is stored in the sampling chamber - the gear motor 21 is reversed and the sampling chamber 39 is closed. By rotating the cutting sleeve, the tissue is severed by the cutting edge 72 of the cutting sleeve 3 during the closing process. Due to the special design of the sampling chamber and as a result of the vacuum applied, the tissue sample is held in the sampling chamber in a rotationally secured manner, so that the tissue sample is not twisted or distorted by the cutting sleeve 3 which surrounds the outside of the biopsy needle and can be rotated longitudinally, as described. After the sampling chamber is closed, the DC gear motor for the vacuum generation unit 5 is activated. The piston 54 is first moved back until the piston releases the ventilation hole (Fig. 11c). After the vacuum in the system has been reduced, the piston moves to the vacuum floor so that the ventilation hole is closed again to prevent the outflow of body fluid (cytological fluid). The flashing of the sample removal diode 92 stops. The ejection diode 93 lights up green. The biopsy needle with the sample chamber closed is pulled out of the cannula. After the biopsy unit has been removed and a vessel has been prepared for the tissue sample and fluid, the program button 89 is pressed again and the ejection diode 93 begins to flash. First, the gear motor 21 of the cutting sleeve is operated to open the sample removal chamber approximately halfway. Then the

\ DC gear motor 58 of the vacuum/pressure generating device is activated. The direction of rotation of the DC gear motor 58 remains the same and the threaded spindle 53 with piston moves towards the syringe base, so that an overpressure is now created in the system. The piston is advanced to the piston base, the drive motor 58 is deactivated. The gear motor 21 moves the cutting sleeve further back above the sampling chamber after the piston has reached the piston base. As a result of the overpressure built up in the system, the sample is pressed out under pressure into a waiting laboratory vessel even when the sampling chamber is half open, at the same time the cavity of the vacuum/pressure generating device, the biopsy needle and the sampling chamber are freed of tissue particles and liquid. The sample is ejected when the sampling chamber is approximately half open because this ensures that the tissue sample is ejected and not by

premature reduction of the excess pressure causes the tissue sample to fall back into the sampling chamber. The narrowing of the biopsy needle cavity by the stopper 79, which made it difficult or impossible for tissue to penetrate the biopsy needle cavity, has proven to be particularly advantageous when taking samples, as the narrowed cross-section increases the ejection pressure. The best ejection results were therefore achieved with the sampling chamber half open; ie the cutting sleeve frees up half of the sampling chamber. The excess pressure also forces the tissue fluid out of the sampling chamber and cleans it.
Once the sampling chamber is fully opened, sampling and cleaning is complete and 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 another sample is to be taken from the same tissue environment, the operator presses the program button 89 and the reset diode 91 begins to flash. The vacuum/pressure generating device, such as the cutting sleeve, is set up again as described. Once 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 as often as required. Once completed, the operator only has to decide whether he wants to take another sample or whether sampling is complete and the housing cover is opened.

If it is necessary to take the sample from a location on the tumor that is not directly above or at the sampling chamber after injection, e.g. to the side of it, the position of the sampling chamber 71 can be rotated using the knurled screw 80. So that the operator can recognize this radial position of the sampling chamber, a marking in the form of a notch 119 is provided on the knurled disk, which points upwards when the opening of the sampling chamber is facing upwards. In the position set, the biopsy needle is fixed by the surfaces of the polygon 50 and the elastic forces in the carrier part. The process of taking the sample is the same as already described.

After completion of the biopsy, the exchangeable element 20 (vacuum pressure device, biopsy needle/cutting device with all elements arranged on it) is removed upwards after the cover has been released. In order to make it impossible to open the housing when the clamping slide is tensioned, a safety wing 84 is arranged on the biopsy needle carrier, which rests against the left front surface 85 of the closure device when tensioned. The closure device, which can be moved in the X-axis, can therefore no longer be moved to the left into the open position and the nose 12 can therefore no longer be removed from the recess 45. Conversely, the housing cover cannot be closed if the carrier unit was inserted when tensioned, since the

^ The safety wing prevents the latch from being inserted into the space provided for it. The surface 85 of the latch abuts the safety wing. The battery charging diode 96 is switched off as soon as the housing cover is opened. When the cover is closed and the insert element 20 is inserted, the battery charging diode indicates whether there is sufficient energy available.

In principle, it is conceivable that all steps for taking a sample and clamping the slide, etc., are controlled individually by hand by activating and deactivating the two gear motors. However, it is advisable for individual steps of the process to be combined and run automatically, and only the initiation of the next step is started by pressing a switch.

" is set. This semi-automatic method, as previously described, has proven to be particularly advantageous.

Basically, two methods are conceivable 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 out or pushing in, and measuring the axial displacement of the cutting sleeve or the biopsy needle carrier. In order to record 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 also placed on the cutting sleeve, while with 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 is used, no additional positioning finger is required. The embedded photocells are covered with suitable, transparent material to prevent possible contamination. The positioning finger 103 passes through a slot in the biopsy needle holder. At appropriate points on the extension 46 of the base block 8, recesses 107 are provided in which photocells or microswitches are installed, which interact either with the free end 61 of the piston spindle, with the positioning 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. A sensor is placed on the shaft of the DC motor, which interacts with a photocell placed on the housing of the DC motor. This measures the number of revolutions of the motor.

Since the DC motors work at a speed of approx. 10,000 - 12,000 rpm, depending on the load, and on the other hand the downstream planetary gear arranged on the output side, which interacts with the spindle drive, reduces the number of revolutions considerably, precise longitudinal control is possible. The longitudinal displacement by the spindle drive is proportional to the output revolution and always the same amount and is therefore sufficient as a control signal for the longitudinal displacement. In order to determine the position of the cutting sleeve 3 and the piston 54 at the beginning, i.e. after inserting

F of the removable element and closing the housing cover 10, the DC gear motor 58 rotates the piston 54 to the stop on

the syringe bottom and the DC gear motor 21 brings the

Cutting sleeve drive to zero position by bringing the gear 74 to the stop on 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 previous-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 insert the exchangeable insertion unit easily, the insertion aid shown in Fig. 16, 17) can be used. As shown in particular in Fig. 16, 17, the biopsy needle carrier is surrounded by two tabs 108 and is secured by an additional

The web 109 is axially fixed in the holder so that it lies parallel to the vacuum/pressure device in the insertion aid. The vacuum/pressure generating device is also enclosed 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 so that they can easily be inserted into the handpiece from above using the holding pieces 117. Since the parts with the insertion aid are sterilely packaged, the replacement element 20 can be removed from the packaging without touching it with your hands and inserted sterilely into the handpiece 1. The tabs are slightly beveled to make it easier to insert the vacuum/pressure generating device and the biopsy needle carrier. Since the insertion aid is made of plastic, the parts to be inserted can be easily held by clamping by selecting the appropriate tolerance and flexibility.

Claims (42)

1. Biopsy device consisting of a handpiece into which a hollow biopsy needle is inserted, wherein a part of the part of the biopsy needle protruding beyond the handpiece can be inserted into the tissue to be examined with its sample removal space and the tissue is sucked into the sample removal space by means of a vacuum and then separated by means of a sample separation device and then removed, characterized in that the vacuum generation device is used to eject the sample to generate an overpressure, the vacuum/pressure generation device ( 5 ) and further control and supply devices are integrated into the housing of the handpiece ( 1 ), and the connecting element ( 4 ) from the biopsy needle ( 3 ) to the vacuum/pressure generation unit ( 5 ) is arranged directly on the housing, the vacuum/pressure generation device ( 5 ) consists of a controllable piston/cylinder unit ( 69 ) which has a ventilation bore ( 67 ), that all drives are electrically operated and that the drive for the clamping slide is also used as the drive for the cutting sleeve, that the biopsy hollow needle is surrounded by an external, coaxial cutting sleeve and that at the transition from the biopsy hollow needle to the sampling chamber a plug protrudes from above which significantly narrows the cross-section of the biopsy hollow needle and that on the front of the housing there is a circuit board for operating the electronics, into which the de-gridding of the clamping slide is integrated. 2. Biopsy device according to claim 1, 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 opened to release the vacuum by retracting the syringe piston ( 54 ). 3. Biopsy device according to claim 1 and 2, characterized in that the piston ( 54 ) of the vacuum/pressure generating device ( 5 ) is movable in both directions by means of a controllable spindle drive ( 53 , 48 ). 4. Biopsy device according to claim 3, characterized in that a high-speed electric direct current motor ( 58 ) with a downstream planetary gear is used as the drive for the controllable spindle drive ( 53 , 48 ). 5. Biopsy device according to claim 4, characterized in that the transmission from the planetary gear to the piston spindle ( 53 ) takes place via a single-stage toothed gear, wherein the threaded spindle nut ( 48 ) placed on the syringe cylinder carries a toothed ring 55 on the outside. 6. Biopsy device according to claims 1-4, characterized in that the piston ( 54 ) for generating a vacuum in the system and in the sampling chamber is moved in a first step away from the syringe base ( 52 ) until shortly before the ventilation bore ( 67 ). 7. Biopsy device according to claims 1-4, characterized in that for ventilating the system the piston ( 54 ) is retracted beyond the ventilation bore ( 67 ) in a second step following the first step and is retracted again after the vacuum has been released in order to close the ventilation bore. 8. Biopsy device according to claims 1-4, characterized in that the piston ( 54 ) is moved in a third step following the second step in the direction of the syringe bottom ( 52 ) in order to generate an overpressure in the system and in the sampling chamber. 9. 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 such that the piston ( 54 ) is retracted from the cylinder in a first step until shortly before the ventilation hole ( 67 ), in a second step the ventilation hole ( 67 ) is released and after the vacuum has been reduced the ventilation hole is closed again, and in a third step is moved in the opposite direction to generate the overpressure towards the syringe base ( 51 ) in coordination with the control of the sample removal and the ejection of the sample. 10. Biopsy device according to one of the several of claims 4-9, characterized in that the speed of the direct current motor is measured by a photocell arranged fixedly on the motor housing and a sensor arranged on the motor shaft. 11. Biopsy device according to claim 10, characterized in that the number of revolutions of the motor is compared with a target value previously stored in the electronics and used as a trigger for controlling the spindle drive. 12. Biopsy device according to claim 1, characterized in that the interior of the hollow biopsy needle ( 2 ) is connected via a connecting piece ( 4 ) to the interior of the vacuum/pressure device ( 5 ) in such a way that no air can flow in from the outside in the case of negative pressure or flow out in the case of positive pressure. 13. Biopsy device according to claim 12, characterized in that the connecting piece ( 4 ) is a flexible tube arranged in the immediate vicinity of the handpiece ( 1 ). 14. 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 has a round cross-section and coaxially surrounds the biopsy needle, as well as parts of the drive, the connecting element ( 4 ) and the vacuum/pressure generating device ( 5 ) form a removable, exchangeable element ( 20 ) which can be inserted into the handpiece ( 1 ). 15. Biopsy device according to claim 14, characterized in that the removable biopsy needle carrier ( 37 ) can be inserted into the tabs ( 40 ) of the clamping slide ( 28 ) by means of the recesses ( 77 ). 16. Biopsy device according to claim 15, characterized in that the clamping slide ( 28 ) is brought into the clamping position via a spindle drive ( 73 , 75 ) driven by a DC gear motor ( 21 ) with a downstream single-stage gear ( 23 , 74 ). 17. 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. 18. Biopsy device according to one or more of claims 14-17, characterized in that a toothed roller ( 23 ) is seated on the output shaft of the planetary gear connected downstream of the DC gear motor, into which the gear wheel ( 74 ) of the spindle drive ( 73 , 75 ) connected to the cutting sleeve ( 3 ) engages. 19. Biopsy device according to claim 18, characterized in that the gear wheel ( 74 ) placed on the spindle drive ( 73 ), ( 75 ) is supported on a holder ( 36 ) of the base block ( 8 ) when the clamping slide ( 28 ) is displaced. 20. 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 are held in the biopsy needle carrier ( 37 ) at two bearing points ( 75 , 49 ) such that the biopsy needle ( 2 ) and/or the cutting sleeve ( 3 ) can be rotated individually. 21. 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 200 hph is applied in the sampling chamber ( 71 ). 22. Biopsy device according to claim 1, characterized in that the constriction comprises 60-75% of the cross-section and that the constriction projects into the cross-section from above. 23. Biopsy device according to claim 22, characterized in that the constriction is a plug approximately 10 mm long. 24. Biopsy device according to claim 1, characterized in that the constriction is designed as a lip or nose protruding into the cross-section. 25. Biopsy device according to one or more of the preceding claims, characterized in that only approximately 25% of the cross-section of the sampling chamber ( 71 ) is open at the top. 26. Biopsy device according to claim 25, characterized in that additional means, such as knobs to improve the adhesion of the sample, are arranged in the sample removal space. 27. Biopsy device according to claim 20, 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. 28. 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 serves both for fastening and for supporting, storing and holding the individual components such as clamping slide ( 28 ), biopsy needle carrier ( 37 ), vacuum/pressure generating device ( 3 ) and drive devices ( 105 , 106 ). 29. 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 ), the actuation of which releases the energy supply. 30. Biopsy device according to claim 29, characterized in that the switching pin ( 19 ) of the microswitch ( 18 ) is actuated by pressing down the vacuum/pressure generating device ( 5 ) by means of the housing cover ( 10 ). 31. 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 clamping slide is tensioned and the biopsy needle carrier is inserted, or prevent the housing cover from opening when the housing is closed. 32. Biopsy device according to one or more of the preceding claims, characterized in that surfaces are provided on the housing for fastening the handpiece to a positioning device. 33. 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. 34. Biopsy device according to one or more of the preceding claims, characterized in that a plastic part ( 47 ) with a knurled disk ( 80 ) is frictionally mounted on the right end (proximal end) of the biopsy needle ( 2 ). 35. 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 when rotated by means of the knurled disk ( 80 ), the biopsy needle ( 2 ) and thus the sampling chamber ( 71 ) is locked in the selected position in the biopsy needle carrier ( 37 ). 36. Biopsy device according to one or more of the preceding claims, characterized in that the space for the gear motors is separated from the rest of the space at the top by a cover ( 46 ) connected to the base block ( 8 ). 37. Biopsy device according to one or more of the preceding claims, characterized in that the battery compartment is separated from the rest of the compartment at the top by a partition plate ( 144 ). 38. Biopsy device according to claim 17, characterized in that a double-armed lever ( 33 ) is used which is adjustable about an axis ( 35 ) under spring pressure, on one arm ( 100 ) of which a compression spring ( 34 ) acts, and the other arm ( 99 ) of which engages in a recess ( 82 ) of the clamping slide ( 28 ). 39. Biopsy device according to claim 1, characterized in that the function display and operating switches for the electronics are integrated into the circuit board. ( Fig. 7) 40. 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 ). 41. Biopsy device according to claim 40, characterized in that the plastic part ( 112 ) is sealed from the plastic part ( 47 ) by means of an O-ring. 42. Biopsy device according to claim 14, characterized in that the removable element ( 20 ) is a sterile packaged unit.