ES2370356T3 - BIOPSY DEVICE AS WELL AS A BIOPSY NEEDLE MODULE THAT CAN BE INSERTED IN THE BIOPSY DEVICE. - Google Patents

Abstract

Biopsy device for tissue extraction as a handpiece with at least one tensioning and launching device that can be requested with elastic force in the form of a tensioning carriage (28) for a biopsy needle unit, which has a needle outer hollow (3) with a distally sharp cutting blade as well as a hollow biopsy needle (2) placed inside the outer hollow needle (3) with a tissue sample extraction space (71) provided in its area of distal end, which is placed in a biopsy needle holder (37), which can be brought into operational contact with at least the tension carriage (28), in which the distal needle areas of the outer hollow needle (3) and of the hollow biopsy needle (2) for tissue removal protrude from the carcass, and, in which the handpiece has a carcass with a carcass cover (10), in which in case of an open position they can be integrated firmly components in the inside the housing, characterized in that a pressure source (5) is provided that can be attached with the hollow biopsy needle (2), and because inside the housing - at least a first and second drive unit ( 21, 58), in which - being able to take the tension car (28) it can be brought into operational contact with the first drive unit (21) so that the tension car (28) can be transferred to a tensioned state and can be locked in the latter, and may carry a drive means (74) placed in the outer hollow needle to operative contact with the first drive unit (21), whereby the outer hollow needle (3) can be rotated around the longitudinal direction of the needle, so that the outer hollow needle (3) is displaced with respect to the longitudinal axis of the needle of the hollow biopsy needle (2), and - the pressure source (5), which is tightly connected to gases in the pr zone proximal of the biopsy needle (2) hollow with it through at least one connecting duct (4) and which can be brought into operational contact with the second drive unit (58) to generate a pressure level, the duct running of connection (4) at least partially inside the housing.

Description

Biopsy device as well as a biopsy needle module that can be inserted into the biopsy device

Technical field

The invention relates to a biopsy device for tissue extraction as a handpiece with at least one tension carriage that can be requested with elastic force for a biopsy needle unit, which has an outer hollow needle with a cutting blade. distally sharpened as well as a hollow biopsy needle placed inside the hollow needle, with a tissue sampling space provided in its distal end area, the outer hollow needle being placed relative to the hollow biopsy needle of sliding way, as well as with a pressure source, which can be attached with the hollow biopsy needle. In addition, a biopsy needle module suitable for the operation of the biopsy device is described.

State of the art

From document DE 40 41 614 C1, a so-called biopsy instrument can be noted, which is configured as a manual instrument and has a partial vacuum source as well as a biopsy cannula connection, which can be moved in rotation by means of a rotational drive joined through a flexible shaft. In the biopsy cannula connection a biopsy cannula configured as a hollow cannula can be placed, which preferably has a distally sharp surrounding cutting edge, hollow channel along which a partial vacuum can be applied by means of the partial vacuum source , which is configured as a cylindrical piston unit, as soon as the hollow cannula is placed in a particular intracorporeal tissue position.

From a biopsy instrument backed by partial vacuum in a similar way, note WO 96/28097 can be taken into account, although it does not provide for any hollow cannula that can move in rotation if it has an injection plunger arrangement disposed within a manual instrument for the generation of partial vacuum.

Document DE 100 34 297 A1 describes, unlike the so-called previous biopsy arrangements with only a single hollow needle, a tissue removal endoscopy instrument that has a biopsy needle arrangement that provides for a sharp hollow needle that runs around from its distal end and a hollow biopsy needle conducted inside the hollow needle, the biopsy needle driven inwardly at its distal end presenting a recess for tissue tissue extraction. A suction instrument for the generation of partial vacuum is provided on the proximal side with respect to the hollow biopsy needle. A tissue extraction is performed so that the biopsy needle arrangement in a joint position advances to an area of tissue to be tested, the biopsy needle providing a distal tip that raises a part on the distal side of the hollow needle to favor on the one hand the process of introducing the biopsy needle arrangement in the tissue and to prevent on the other hand the introduction of tissue into the hollow needle. In case of proper placement of the biopsy needle arrangement within the tissue, the hollow needle is dragged a defined part towards the proximal side, the biopsy cannula remaining in its position remaining in its position and releasing the recess. The partial vacuum applied along the biopsy needle causes an active reduction or removal of surrounding tissue parts in the recess. By means of the controlled advance on the distal side of the hollow needle with its sharp distal end through the biopsy needle, a part of tissue is separated and included within the recess of the biopsy needle. By removing the biopsy needle arrangement together, the tissue sample is then removed exorporally for testing purposes. The entire tissue extraction process described above is performed so that the movements of the needle as well as the application of partial vacuum are performed manually individually and separately from each other.

In contrast, the biopsy needle arrangement described in WO 98/25522 allows a relative movement requested by elastic force between the hollow biopsy needle that is inside and the outer hollow needle that surrounds the needle of biopsies In this case, too, the biopsy needle is placed to take tissue on the distal side with respect to the sharp distal tip of the hollow needle, a partial vacuum source is provided for the partial vacuum supply directed through the needle. of hollow biopsies in the area of its recess and supporting the process of tissue introduction. The process of placing the biopsy needle in a relative manner and finally within the area of tissue to be tested is performed exclusively manually. Such placement leads especially in the case of testing hard tissue areas to unsatisfactory biopsy results.

In addition to document GB 2 018 601 A as well as document EP 0 890 399 A1, similar vacuum-backed tissue extraction devices can be noted, since in these cases the sources of partial vacuum as well as other control units necessary for driving Controlled biopsy needle are configured and provided as additional external units that will be attached to the biopsy needle arrangement.

Also described in US 2001/0011156 A1 is a vacuum-backed biopsy device that provides for a compactly configured manual instrument, in whose housing all the necessary actuating elements for the needle arrangement of the needle arrangement are provided. of biopsies. However, a source of partial vacuum is provided separate from the manual instrument, which can be attached through

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of a corresponding supply conduit with the needle arrangement inside the manual instrument in a suitable joint position.

The state of the art according to DE-A-10026303 is outlined in the preamble.

US-A-6142955 has an external needle that can be moved longitudinally and rotatably disposed.

Description of the invention

Starting from the biopsy needle arrangement considered the most recent state of the art according to WO 98/25522, the objective is based on perfecting a biopsy device for tissue extraction that is configured as a handpiece and at least a tensioning and launching device that can be applied with elastic force in the form of a tensioning carriage for a biopsy needle unit, which has an outer hollow needle with a sharply distally sharpened blade as well as a hollow biopsy needle placed inside the hollow needle with a tissue sampling space provided in its distal end zone, in which the outer hollow needle is positioned relative to the hollow biopsy needle in a sliding manner, and provides a source of pressure that can be attached with the hollow biopsy needle, so that the operating comfort of the biopsy device is optimized so that a study can be guaranteed Improved tumors, presenting the sample of removable tissue with the biopsy device a size and structure that offer a pathologist excellent fundamental notions for other histological studies. It is also valid to improve the tissue extraction process itself. This means in particular that the needle movements necessary for the tissue separation process of the biopsy needle unit as well as the generation of pressure in the direction of a directed establishment of a partial vacuum must be adjusted exactly together. Such a largely manual adjustment between needle movements and partial vacuum generation, as in the case of WO 98/25522, should be avoided.

In view of improved handling comfort, the biopsy device must also have a structural form that is as compact as possible and, as a necessary instrument, allow independent operation with one hand, so that a single operator can carry out the process of tissue extraction with one hand. In the same way, the biopsy device must be configured as a manual instrument that works autonomously that does not require any external control or supply unit for its operation, for which connection conduits that run from the manual instrument would be provided, In particular, this refers to avoiding a connection conduit to an external partial vacuum source or current supply.

In addition, the pressure source, which should preferably facilitate the generation of a partial vacuum, must be configured as easily as possible and operate reliably. The extraction of tissue samples should possibly be done in a way that should be provided to the user, who in most cases is a pathologist, a sample of non-twisted tissue and not damaged for evaluation.

The biopsy device should ultimately require only a low expense and facilitate an economical solution with respect to replaceable biopsy needles that are considered consumable material.

The solution of the objective on which the invention is based is indicated in claim 1 which describes a biopsy device configured according to the invention. The subject of claim 33 is a biopsy needle module that can be implemented for the functional use of the biopsy device according to the invention therein. Furthermore, a process for the extraction of tissue with the aid of the biopsy device according to the invention results from claim 50. Certain features that advantageously refine the idea of the invention are subject to the dependent claims and can be deduced from the text of the description, especially with reference to the embodiments.

The biopsy device according to the invention for tissue extraction by way of a handpiece with at least one tensioning and launching device that can be requested with elastic force in the form of a tensioning carriage for a biopsy needle unit, which has a outer hollow needle with a distally sharp cutting blade as well as a hollow biopsy needle placed inside the hollow needle, with a tissue sampling space provided in its distal end zone, in which the outer hollow needle can placed with respect to the hollow biopsy needle in a sliding manner, as well as with a pressure source that can be joined with the hollow biopsy needle, is characterized according to the invention because the handpiece has a housing in which they are integrated so that At least two drive units and the tension and launch device configured as a tension carriage can be released and signed. The two drive units as well as the tension carriage are configured and arranged inside the housing so that in an open position of the housing cover the biopsy needle unit contained in a biopsy needle holder as well as a source of Pressure attached to the biopsy needle unit can be implemented inside the housing and come into proper operating contact with the components mentioned above that are there. In this regard, the biopsy needle unit is connected with its hollow biopsy needle through a gas-tight connection conduit with the pressure source and represents in itself a module of

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unitary biopsy needle to be considered for sterility reasons a disposable article.

The biopsy needle holder serves on the one hand as a mechanical housing structure for the biopsy needles, of which at least the outer hollow needle, as set forth below in particular, can be moved through a spindle mechanism by rotation around the longitudinal axis of the needle along the

5 hollow biopsy needle. On the other hand, the biopsy needles are joined so that they can be released and signed together through the biopsy needle holder with the tension carriage, by means of which the impact process of the two biopsy needles is carried out together in an area of tissue to be tested. For this, the biopsy needle holder has a suitable coupling structure that can be inserted into a corresponding coupling counter structure provided in the tension carriage.

10 The biopsy needle holder has, in a preferred embodiment, an open housing module on one side, from which the open biopsy needles can be integrated so that they can be released and firmly attached to the biopsy needle holder. In addition, the open configuration on one side of the biopsy needle holder offers the possibility of mechanical gearing of a drive means placed on the outer perimeter of the outer hollow needle in a gear component that is placed on the secondary axis of a of the units of

15 drive. By means of this kinematic operative contact that exists between the outer hollow needle and the drive unit, the outer hollow needle is rotatably rotated, so that it moves with respect to the longitudinal axis of the hollow biopsy needle needle, which is fixedly arranged in a longitudinal direction of the needle with respect to the biopsy needle holder. Exactly through the same kinematic operating mechanism the tensioning car tension process is also carried out at the same time, the

20 biopsy needle holder together with the biopsy needle arrangement in the tension direction together with the tension carriage until reaching the tension position, longitudinally movable with respect to the hollow biopsy needle, in which to reach a mechanical stop of the hollow outer needle.

Therefore, it is possible to operate two functions with the help of only one drive means, namely the tension of the tension carriage and at the same time the control of the movement of the biopsy needles that

25 is not limited only to a capacity of relative longitudinal displacement of both biopsy needles but, as other embodiments show, optionally also includes additional rotational movement paths around the longitudinal axis of the needle.

In addition to the drive unit mentioned above, the second drive unit serves exclusively for the directed generation of a pressure level within the hollow biopsy needle and the space

30 for extracting tissue samples linked with it. The pressure level represents an overpressure or partial vacuum depending on the respective work stage performed with the biopsy device that can be generated and adjusted in a directed manner with the pressure source.

With the help of the biopsy device configured according to the invention, it is possible to extract tissue samples that can be performed completely autonomously, which can also be performed by a doctor in the

35 context of one-handed operation. All the processes necessary for the extraction of tissue samples are performed automatically, that is to say without additional manual support and can be activated respectively by means of individual key drives in the biopsy device itself.

The individual steps for complete tissue extraction are performed by the biopsy device as follows:

40 - Transfer of the biopsy needle unit as well as the tension carriage to a starting position. This first stage corresponds to a type of resume function. -Transfer of the tension carriage to a stressed state, -Activation of the trip, with which the biopsy needle unit is triggered distally in a tissue space to be tested,

45 -Automatic establishment of a partial vacuum that can be applied by the pressure source through the joint duct along the hollow biopsy needle in the tissue extraction space, -Tissue separation process in which the needle outer hollow travels to the proximal side and at the same time the tissue extraction space is released under partial vacuum conditions, so that the surrounding tissue material is suctioned into the tissue extraction space and separated from the rest of the tissue by means of the

50 cutting action along the longitudinal edges configured as blades that laterally delimit the tissue extraction space, the separation process being further supported by a change of movement directed on the distal and proximal periodic side of the hollow biopsy cannula , so that finally the partially separated and suctioned tissue sample in the tissue sample extraction space is completely separated by advancing towards the distal side of the outer hollow needle,

55 and -Extraction process of tissue samples that is performed extracorporeally, in which the outer hollow needle unlocks at least partially the space for extracting tissue samples on the proximal side and by applying an overpressure on the biopsy needle especially in the lower area of the tissue sample extraction space there is a detachment of the tissue sample, from

60 so that the tissue sample can be easily removed from the tissue sample extraction space.

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The work steps described above for careful tissue sample extraction can be performed reliably and safely using the biopsy device according to the invention. Of special significance is the total independence of the biopsy device from the external instruments that support the tissue extraction process with high simultaneous handling comfort that allows one-handed operation without problems. The biopsy device is explained in particular with reference to the embodiments described below.

The biopsy device is particularly advantageously characterized by the control panel to be activated by a doctor in charge of the treatment, which is provided on a side outer wall of the biopsy device housing and preferably has only three control keys respectively which are specially placed within sight and can be handled completely correctly. Thus, light signal panels are assigned, for example, to each control key, which inform the doctor about the current manageability of the individual control keys and also guarantee a fixed function development in a fixed manner according to the development of the described procedure. previously. The functions to be carried out especially with care, such as the tension of the tension carriage or the function of the tissue sample extraction process, are time-delayed, so that their activation cannot be carried out by mistake. The biopsy device is advantageously characterized by these and a large number of additional features, as can be deduced below with reference to the following embodiments.

Brief Description of the Invention

The invention is described below by way of example, without limiting the general idea of the invention, by way of exemplary embodiments with reference to the drawings. They show:

figure 1

a biopsy device with open housing cover (in perspective)

figure 2

a handpiece with the parts of the biopsy device arranged therein (without cover or

casing base) and interchangeable biopsy unit; (raised in perspective)

figure 3

a longitudinal section A -A through the biopsy needle in Figure 1

figure 3a

a longitudinal section A -A through the biopsy needle in Figure 1 (like Figure 3) of the

proximal part (augmented)

figure 3b

an increase in detail A in figure 3a

figure 3c

an increase in detail B in figure 3a

figure 4

a cross section A -A in figure 3 (part of the left housing)

figure 5

a cross section B-B in figure 3 (part of the right housing)

figure 6

the end cover of the right housing (internal side) with integrated microswitch

figure 7

the front side of the control panel

figure 8a

the base block on the X axis viewed from the front (in perspective)

figure 8b

the base block on the X axis seen from behind (in perspective)

figure 9a

a manual part with the fixed housing units of the biopsy device without base or cover

the housing in the unstressed state

figure 9b

the retention device in the relaxed state (section A -A)

figure 10a as figure 9, but with tension carriage in tensioned position figure 10b as figure 9a, but in tensioned position and in locked state figure 11a a side view of biopsy needle tip figure 11b the longitudinal section a through figure 11a (open sample extraction space) figure 11c as figure 11b, but (semi-open sample extraction space) figure 11d as figure 11b (sample extraction space closed by means of cutting sleeve ) figure 11e section A -A in figure 11a figure 11f section BB in figure 11a figure 11g an increase of the section edge in A

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Figure 12 a biopsy needle holder with a biopsy needle / cut-in sleeve snapped in and a plastic part (from below, rotated approximately 90 °, in perspective)

Figure 12a a section through the longitudinal axis of the proximal part of the biopsy needle (enlarged)

Figure 12b a section B-B through the multiple edge of the biopsy support in the rotated state, with a stop on the left side

Figure 12c a section B-B like Figure 12b, but with central position of the multiple edge

figure 12d a section B -B like figure 12b, but with a stop on the right side, turned

Figure 12e a section A-A through the zone 0 of deformation of the needle of the biopsy needle and the cutting sleeve

Figure 12f a biopsy needle on the distal side with sample extraction space and cutting sleeve in normal position, corresponding to the position of the multiple edge in Figure 12c

figure 12g a biopsy needle like figure 12f with rotation of the sample extraction space towards the

right and advanced cutting sleeve, corresponding to the position of the multiple edge

according to figure 12d

figure 12h a biopsy needle like figure 12f with rotation of the sample extraction space and retracted cuff, corresponding to the rotation of the multiple edge according to figure 12b

Figure 13 a vacuum / pressure device, assembly and drive (seen from behind, in perspective)

Figure 14a a vacuum / pressure device with plunger supported on the injection base (starting position for the generation of vacuum and final position for the generation of pressure, partially sectioned)

Figure 14b a vacuum / pressure device with piston removed; final position of the vacuum piston stroke (partially sectioned)

Figure 14c the position of the piston after unlocking the vent hole; pressure compensation position; partially sectioned)

Figure 14d a section A -A through the threaded spindle in Figure 14c

Figure 15 a base block and biopsy needle / cutting sleeve, prepared for the equipment with photocells and microswitches for the detection of the real value

Embodiment of the invention, commercial applicability

In the exemplary embodiment according to figure 1, all the components necessary for performing a vacuum biopsy are integrated into the internal space of the housing of a handpiece 1, so that no cable or conduit is necessary from the housing from the handpiece to other external supply devices. Handpiece 1 therefore represents a complete vacuum biopsy device, which can move freely in all directions. From the end cover of the distal housing 6, the distal part of the hollow biopsy needle 2 protrudes with the outer hollow needle 3 that coaxially surrounds it, which is referred to below as the cutting sleeve; It serves to extract or completely separate the tissue sample. In most cases, a coaxial cannula, not shown, is placed in the tissue at the beginning of the biopsy, into which this part of the biopsy needle 2 with cutting sleeve 3 is inserted and thus placed in front of the tissue to be tested. Outside the end cover of the right proximal housing 7, a connecting element 4 is provided, for example a transparent flexible tube, which gasically joins the pressure source or vacuum / pressure generating device 5 arranged in a manner parallel to the biopsy needle with the internal hollow space of the biopsy needle 2. The hollow junction element 4 in direct proximity to the end cover of the housing 7. The biopsy needle 2 disposed in a biopsy needle holder 37 with cutting sleeve 3 and other elements forms a biopsy needle module 20 that can be easily pulled up and inserted, designated below as an element that can be removed with the connection element 4 and the vacuum / pressure generating device 5 , which is changed according to need (figure 2). For this, the housing cover 10 is opened. As shown in particular in figure 2, the biopsy device can be articulated in parts that are firmly connected with the housing (disinfected parts), and in an element 20 that can be removed (sterile part)). While the parts firmly connected to the housing are only disinfected, the element 20 that can be removed is supplied sterile packaged and as needed is renewed in case of new patients. As discussed in more detail below, attention is paid to the fact that the disinfected part in case of use is not contaminated with tissue fluid.

In the exemplary embodiment described below, the vacuum / pressure generating device (5) is arranged parallel to the biopsy needle unit. However, in the context of the invention, the device

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vacuum / pressure generation can be arranged horizontally also placed on the axis of the biopsy needle or the handpiece; Neither is its own connecting element necessary when it is placed, for example, directly at the end of the biopsy needle, in which case the connecting element is considered a suitable flanged joint, for example in the form of a Luer coupling closure.

Between the end cover of the housing 6, 7 left and right is a lower part of the housing 9 and a cover of the housing 10 rotatably placed in the end covers of the housing with a latch

11. Through tensioners or screws, which are partially screwed into a base block 8, the lower part of the housing 9 is caught between the end cover of the housing 6, 7, or joins with the base block 8. The housing cover 10 is rotatably connected through an axis fixed on the end covers of the housing 6, 7. The housing cover 10 is closed before operation of the biopsy device; the internal contour of the housing cover corresponds to the external contour of the biopsy needle holder 37 described precisely below. Approximately in the center of the internal space of the housing is arranged the base block 8 which is firmly connected with the lower part of the housing, for example, through fasteners and / or through a screw joint. The drive elements for the vacuum / pressure generating device 5, the cutting sleeve 3 and the tensioning device for the tension carriage 28, on which the biopsy needle holder 37 is placed 37 are connected with the base block 8. The base block 8 extends from the center of the housing to the left and a plate added thereto covers the drives and serves to store the control printed circuit board that is disposed in a protected manner inside or below the cover 46 In addition, the base block 8 has in each case a support 36 open upwards for the biopsy needle / cutting sleeve and another insertion element 62 for the vacuum / pressure generating device.

To describe the position of the individual elements, as well as the position of the individual parts, especially in the internal space of the housing, a cross of coordinates was marked in figure 1, the central coordinate point of the coordinate system being found in the center of base block 8 (figure 1). Next for the following description for the direction indications, seen in the direction of the X axis is considered left (distal) and seen opposite to the X axis is considered right (proximal). For the other coordinates in the direction of the Y axis it is considered above, opposite to the Y axis it is considered below and in the direction of the Z axis it is considered behind and opposite to the Z axis it is considered ahead (figure 1). The coordinate system divides the internal space of the housing and the other references, therefore, in left and right, in front and behind as well as up and down. In the case of the angular rotation movement of the biopsy needle, the rotation around the entire longitudinal axis of the biopsy needle and the cutting sleeve to the left (i.e. forward) and right (apart from this determination) were selected. backwards) for an easier understanding. With reference to these determinations, for example, in the part of the lower, anterior, left housing part of the internal space of the housing, all the actuating devices 106 for the tensioning device and the cutting sleeve as well as in the part of the lower housing , on the left, the drive device 105 (figure 13) for the vacuum / pressure generating device 5. In the lower part, the power supply for the drive motors and the usual electrical equipment is housed, for example for the elements of control and / or surveillance; Preferably, batteries or an accumulator 111 are used, for example a 7.2 V lithium ion battery, 1 Ah. The internal space of the front, right, upper housing, which is located above the battery space, is largely used for the tension carriage 28 with locking part (Figure 5); which is connected to a block 26, which is part of the base block 8. The battery space is sealed upwards by means of a separator plate 114.

A biopsy needle holder 37 is disposed in the highest, anterior part of the internal space of the housing, which can be removed and inserted into the U-shaped insertion holder 36, open upwardly from the base block 8 and in the tongue 40 arranged on both sides of the tension carriage 28, which points upwards, in which the biopsy needle unit / cutting sleeve with actuating parts is rotatably positioned, which reaches almost the entire length of the handpiece. The biopsy needle holder, as described below, can be moved longitudinally by means of the tension carriage. This means that in the unstressed state, the left front surface of the biopsy needle holder 37 is almost in contact with the end cover of the left housing 6, in the tensioned state the right front surface is in contact with the cover of casing end 7 right. "Almost the entire length" means that the biopsy needle holder is at least in magnitude shorter than the internal space of the housing that is needed for the tensioning process. If the tensioning path of the tension carriage amounts to 20 mm, for example, the biopsy needle holder must be able to move at least in this magnitude. In general, the tensioning path is between 15 and 25 mm, depending on the biopsy needle used in each case. Therefore it is convenient to design the internal space on the largest possible tension path respectively plus some mm.

The tensioning device itself (located on the right, in front) is constituted by a tensioning carriage 28 driven in a bolt 30, the bolt being screwed into the block 26 of the base block 8. The bolt 30 is surrounded on the proximal side by a spiral spring 31. On the distal side of the tension carriage another spiral spring 124 is arranged short on the bolt 30. This short spiral spring rests on one side in the block 26 and on the other hand on an inner edge 122 in the distal side in the tension car. On the opposite side (on the proximal side) of the edge of the tension carriage, the spiral spring 31 is supported. The retention device (see especially Figures 9b and 10b) of the tension carriage is fixed to block 26. In the internal space of the upper, rear, right housing is housed the vacuum / pressure generating device 5 with parts of the drive; the gear drive motor

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Reduction for the vacuum / pressure generation device is located in the lower left, rear area of the internal space of the housing.

The housing cover, the lower part of the housing, the end cover of the housing as well as the base block are preferably composed of aluminum.

The handpiece 1 is constituted, as already described, by a housing formed by a lower part of the housing 9 with laterally raised walls differently, the housing cover 10 adapted to the lower part of the housing with the latch 11 that can move longitudinally and the end covers of the housing 6, and 7. The lower part of the housing is connected with the two end covers of the housing through tensioners or screws, for example of iron, which partially they are screwed directly into the base block 8. The housing has a length of approximately 200 mm, the end covers of the housing have approximately square cross-section, approximately 40 x 40 mm, (Figure 2). The housing cover 10 can be rotated around an axis 104 that is fixed on the end covers of the housing 6, 7; holes 14 are used for this in the end covers of the housing. The drag stop 12 of the latch 11 can be inserted in the recess 45 of the base block 8 to move the housing cover. The end cover of the left housing 6 has a U-shaped passage 13 open at the top, anteriorly, for the forward part of the biopsy needle / cutting sleeve 2, 3 and the guide roller 81 arranged on it. The guide roller 81, which in case of the use of a coaxial cannula is placed on it, also prevents tissue fluid from entering the housing. The end cover of the rear casing 7 has two U-shaped steps 15, 16, open upwards. Step 15 corresponds to step 13; houses the end of the plastic part 47 of round cross section placed in the hollow biopsy needle. In step 16, a connection tube 63 of the vacuum / pressure generation device is introduced (Figure 2). Another plastic part 112 incorporated in the plastic part 47 has a pin 17 which serves to connect the connecting element 4 with the outlet connection tube 64 of the vacuum / pressure generating device. The internal hollow space of the biopsy needle is connected continuously through the joint element 4 continuously with the hollow space of the piston / cylinder arrangement and the hollow space of the vacuum / pressure generating device. The joints are configured in such a way that air cannot be introduced from the outside into the system, nor can air be drawn out in the event of overpressure; the binding sites are therefore configured in airtight manner. The system thus configured causes the sealing element 76 to drag in case of applying a partial vacuum inside the biopsy needle against the biopsy needle 2, which although it reinforces the sealing action, however the turning movement of the cutting sleeve with respect to the biopsy needle does not influence negatively, however the biopsy needle in a corresponding configuration rotates together until the rotation is stopped by means of a delimiter device. As shown in particular in Figure 6, in step 16 of the end cover of the housing 7, a microswitch 18 is integrated on the lower side, whose drive bolt 19 enters the passage.

As soon as the connection tube 63 of the vacuum / pressure generating device is inserted in the passage and the housing cover is closed, the actuation bolt 19 of the microswitch 18 is pressed down and the microswitch 18 unlocks the supply of stream. In steps 97, 98 of the housing end cover the connections can be mounted to connect a charger.

On the front side of the lower part of the housing 9 there is provided a surface 113 for the control panel fixed to the housing (figure 7) with the control and monitoring elements. The control panel 57 to be fixed to the housing is configured as an independent component that sticks for example on the surface 113 of the lower part of the housing 9. This control panel 57 is connected through conduits with other electronic components , which are arranged in the housing, as well as with the power supply. Of the electrical / electronic components connected with the control panel, the printed circuit board disposed in the space 39, which is located below the cover 46, should be mentioned. A programmable microprocessor is arranged in the printed circuit board as well as Other electronic components The semi-automatic sequence control described below is controlled by the microprocessor. The control panel contains mainly switches to handle the biopsy device and diodes to control the control development. From a recess 65 in the lower part of the housing, the actuation key 88 for the mechanical activation of the tensioned tension car protrudes and pulls out the control panel located above at this point, so that the actuation key It may feel slightly through the control panel sheet.

In the case of the configuration of the control and surveillance elements, attention was paid to the difference between the tensioning process of the tensioning car and the activation of the activation of the tensioning car on the one hand, and on the other hand the performance of the biopsy, such such as the separation of the sample, as well as especially the extraction of the sample by ejection of the sample. Correspondingly, the drive key 88 (activator) for the tension carriage to the right and the tension key 90 that activates the tension of the tension carriage to the left have been placed. The programming key 89 provided for the biopsy is in the center. In the same way, the control lamps for the resumption, biopsy and ejection of the sample are found in the center, after opening the sample extraction space. By pressing the programming key 89 after inserting the element 20 that can be removed and after closing and locking the housing cover as well as automatically adjusting the initial position, two functions are consulted, namely the extraction of samples and ejection of samples. After inserting the element that can be removed and closing the cover, the resume diode

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91 illuminates briefly with yellow light and flashes during initial position adjustment; After setting the starting position, the resume diode goes out. The sample extraction diode 92 (green) and the tension diode (yellow) light up and indicate that the operator can consult either one or the other function. If you press the tensioning key 90, then bring the tension carriage 28 to the tensioning position and lock it there. To prevent the tensioning key from being pressed by mistake, it is provided with a delayed connection, approximately 1.2 seconds. During the tensioning process the yellow tensioning diode goes out; after finishing the tensioning process the blocking diode (green) lights up; The instrument, that is to say the biopsy needle, is prepared to be tested on the tissue to be tested by activating it by means of the actuation key 88. After the impact the blocking diode goes out and the tensioning diode is illuminated (yellow) and the sample extraction diode (green). Now both functions can be consulted (tensioning or sampling). If the programming key 89 is pressed, the biopsy process is performed automatically, as explained below. However, the tensioning process could also be consulted again. In case of consultation of the biopsy process (sample extraction) it develops automatically. After finishing the process, the sample extraction diode that flashes green turns off and the yellow ejection diode lights. Pressing the programming button again will automatically carry out the sample extraction. After the process is finished, the flashing ejection diode is turned off and the resumed diode is illuminated with yellow light, which means that the element 20 that can be removed can be removed, or that by pressing the programming key the instrument is automatically prepared for extraction of other samples. Then the process is followed again as described, tensioned etc. or sample extraction. If the programming key 89 is pressed for sample extraction (for ejection of the sample), a delayed connection is foreseen to prevent the ejection from being carried out if the programming key is pressed by mistake, without being removed with anticipate the needle.

The battery charging diode 96 indicates the state of charge of the battery, or of the accumulator. The diodes are connected, as already described, so that in case of carrying out the respective process executed the diode flashes and after finishing the process the diode of the following process is illuminated. Whenever there are two possibilities to choose from, the next two diodes light up. It is left to the user's discretion what choice he makes. The colors of the diodes are selected so that the processes in the tissue are indicated with green light, while the external processes are indicated by the yellow color. In the case of the tensioning and sample extraction function, delayed connections (for example 1.2-1.5 seconds) are provided to ensure that the process has been executed on purpose. In the case of the description of the development process, it deals in more detail with the mode of action and the possibility of control in particular. The symbols (pictogram) on the edge symbolize the individual processes.

Figure 8a shows a perspective representation of the base block 8 (viewed from the front in the direction of the X axis); Figure 8b shows the base block 8 from behind on the X axis (both perspective representations). The base block 8 can be divided into two halves seen in the longitudinal direction; the front part serves to fix the entire drive for the cutting sleeve and the tension carriage as well as in its upper part of the biopsy needle holder storage (figure 8a); the rear part is used for fixing the drive for the vacuum / pressure generation device as well as for storing the distal side of the vacuum / pressure generating device (Figure 8b). Between the two drive motors 21, 58, below the central rib 87 is a central electronic printed circuit board arranged in the space 39 below. The base block 8 has on its left, anterior side a U-shaped space 24, in which a toothed roller 23 is mounted, which is driven by the geared motor 21. To do this, the secondary axis of the geared motor is placed or introduced in an opening in the wall 25 of the base block 8. The toothed roller 23 is fitted to the secondary axis and is fixed thereto securely against rotation and displacement, for example, by means of a screw. On the other side, the toothed roller 23 is placed on the wall 22 of the base block 8. A drive motor with a speed of approximately 11000 rpm is used as the drive motor. A planetary gearbox with high reduction is subsequently connected to the direct current motor, on whose secondary axis the toothed roller 23 is placed.

With the wall 22 another block 26 is formed, shown to the right, which houses both the double lever 33 that can be rotated for locking, as well as fixing the bolt 30 for driving the tension carriage 28. The bolt 30 is screwed into the threaded hole 29. The tension carriage 28 slides in case of the tensioning process on the separator plate 114 arranged below it to the right. In the case of the tensioning process, the spiral spring 31 arranged on the threaded bolt 30 is compressed. The spiral spring is supported with one end on an end piece 32 of the threaded bolt or directly on the end cover of the housing 7; the other end of the spiral spring, which enters the blind hole of the tension carriage, is supported by a washer on a lip 122 of the guide hole 115. The threaded bolt 30, which is fixed on one side in the cover of at the end of the housing 7 and on the other hand in the block 26, it has a short spiral spring 124 on its distal side, which also rests on its proximal side on the lip in a blind hole 129 coaxial that faces the hole 115 through another washer 125 in the surrounding lip 122. Both spiral springs have the same diameter and the hole 129, 115 distal and proximal in the tension carriage and the hole 128 on the distal side in the block 26 are configured in diameter so that the spiral springs can be easily fitted. All the holes are arranged coaxially with respect to the bolt 30. At the same axial distance with respect to the surrounding lip in the blind hole of the carriage, the threaded bolt 30 has a shoulder 123. The tension carriage 28 is held in its starting position.

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(rest position) by means of springs 31, 124 slightly pre-tensioned through the washers in rest position, as shown in Figures 3a and 3c. In this regard, the washers are in contact with both the corresponding side of the shoulder and the lip and are perpendicular; therefore, if the carriage deviates to the right or left, then the respective spring is tested, the tension carriage is returned to its starting position, the carriage is maintained in a certain way "floating".

The tension carriage 28 slides mainly on the separator plate 114 and is secured against rotation by means of this and the side wall. An arm 99 of the double arm lever 33 of the retention device engages in a groove 27 of the tension carriage 28 (Figures 9a and 10a). The retention device integrated in the block 26 of the base block 8 is constituted by the double-arm lever 33, which can be rotated around an axis 35 that is perpendicular (seen on the Y-axis) by means of its spring compression 34. The shaft 35, a pin that is perpendicular, is fixed in the holes 38 of the base block. In the relaxed state, the part 99 of the double arm lever is in the groove 27 of the tension carriage; the compressed spring 34 acts on the part 100 of the lever to press the retention key 88 outward (forward). The retention key is on the control panel, which is pressed somewhat out at this point after tensioning, can be easily tempted. As long as the part 99 of the double-arm lever can fit into the recess 82 of the tension carriage, the actuation key 88 is pressed out. The tension carriage is retained by engaging the part of the lever 99 in the state tensioned and can now be activated if necessary with the actuation key 88. Since the tension carriage is conveniently made of plastic, it has proved useful to incorporate a metal part 83 into the cavity so as not to damage the plastic, since the lever Double arm is made of metal. Unlike the element 20 that can be removed, the handpiece with changeable insertion element is used multiple times. The tensioning path corresponds to the depth of penetration of the biopsy needle into the tissue. As a result, it turns out that the length of the lever 99 also corresponds to the tension path. Since the penetration depths are generally between 15 and 25 mm, the same handpiece can be used for different penetration depths by means of the corresponding configuration of the lever length 99 and the corresponding modification of the specifications in the control .

The tension carriage 28 that connects with the block 26 is arranged at the same height with respect to the block 26 and has approximately the same cross section as the block 26. On its upper side, the tension carriage has two tabs 40. The surface 41 of the tension carriage shown upwards, as well as the surface 44 of the block 26 shown upwards, as well as the extension surface 42 of the base block 8 shown upwards together form a flat support surface for the surface slide 43 of the biopsy needle holder 37 to be placed (see Figure 2). The biopsy needle holder is made of plastic. In case of displacement of the tension carriage from the tensioned starting state (figure 9a) to the tensioned state (figure 10a), that is to the right, the biopsy needle holder 37 slides by the tabs 40 on the surface 42 and 44. It is also conceivable that the sliding surfaces are not flat, as configured in the exemplary embodiments, but rather have sliding surfaces configured in a peculiar way; it is important that the biopsy needle holder 37 can slide on the sliding surface in a smooth and straight way and that after activation of the actuation key 88 the biopsy water can be introduced rectilinearly into the tissue, the tumo . Therefore, also the upper external contour of the biopsy needle holder is configured correspondingly to the internal contour of the casing cover and has a single reduced clearance with respect to the casing cover to prevent needle deviation of biopsies upwards, which is also advantageous in case of the tensioning process.

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 support 36, open upwards among other things for the introduction of the needle of biopsies / cuff cut. This support serves primarily as a radial thrust bearing, that is, for the support of the drive part with the cutting sleeve, the toothed wheel 74, or the plastic disk 78, to carry the tension carriage by means of the device drive 106 to its tensioning position. On the distal side, the support also serves as a stop for the projection 127 in case of generation of the movement towards the anterior side and towards the posterior side and the angular rotation movement connected therewith.

At the upper, rear part of the base block, another U-shaped insert 62 is provided, into which the free end 61 (end on the distal side) protruding from the injection body of the threaded spindle of the generating device is inserted. of vacuum / pressure. The insertion element is configured as a channel in which the threaded spindle 53 slides. In the center, upper part of the base block, a fixation is provided for a plate that houses the recess 45, in which the drag stop is fitted. 12 of latch 11 of the housing cover. A cover 46 arranged in the base block 8, shown to the left, separates the space of the drive motors and the used printed circuit board from the top, left of the internal space of the housing, which is used primarily for The storage of the exchangeable biopsy needle holder 37, including the biopsy needle and the cutting sleeve. The cover 46 protects the electric gearmotors and the printed circuit board against fouling. The printed circuit board for electronic equipment is located between the drive motors and below the central rib in space 39.

Figure 2 shows the biopsy needle holder 37, which can be inserted into the tabs 40 of the tension carriage 28 with biopsy needle 2 and cutting sleeve 3 as well as other parts. The round, hollow biopsy needle 2 has

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a needle tip 70, to which the sample extraction space 71 is attached (Figure 11a-11f). The biopsy needle 2 of round cross section is surrounded by a cutting sleeve 3 of round cross section, coaxially arranged, which at its left end directed to the sample extraction space has a disc 72 which serves to remove the sample and keep it in the sample extraction space after the introduction of the biopsy needle (with closed sample extraction space) and after the opening of the sample extraction space and making a movement towards the anterior side and towards the posterior side of the needle , which in a particularly preferred embodiment is simultaneously superimposed by a delimited angular rotation movement, determined above of the biopsy needle about its longitudinal axis, as described in detail below. The disc distally disposed of the cutting sleeve is preferably perpendicular to the longitudinal axis of the biopsy needle and the cutting sleeve. The separation process is preferably carried out by means of the simultaneous rotation and longitudinal displacement of the cutting sleeve by means of the actuation of the threaded spindle. It is also conceivable that the movement of the cutting sleeve is not carried out continuously, but gradually or oscillatingly, that is, the advance moves for short distances forward and backward. As especially shown in Figure 11f in cross-section, the longitudinal edges 68 of the sample extraction space are above the central point of the cross-section, that is, the sample extraction space is raised on the Z axis by approximately 15 - 30º. To improve now the introduction of solid, hard tissue in the sample extraction space, the longitudinal edges have a cut. This cut in the longitudinal edges is generated in this way, reducing the wall thickness from above, so that the width b 'at the cutting edge corresponds to the width b of an internal diameter of the tube of the cutting sleeve that is located deeper, that is the wall thickness is reduced at the top and is thus used to configure the cutting edge (see Figure 11f and an amplification in Figure 11g).

A threaded spindle sleeve 73 with a toothed wheel 74 disposed on the front side of the threaded spindle sleeve is attached to the other proximal end opposite the cut 72 of the cutting sleeve. The threaded spindle sleeve with the cogwheel is securely arranged against rotation and displacement in the cutting sleeve. A threaded spindle nut 75 is engaged with the threaded spindle, which is firmly pressed into the biopsy needle holder 37. The sprocket 74 is located on the left, that is, in front of the spindle sleeve. If the threaded spindle sleeve is rotated by means of the sprocket 74, the cutting sleeve is rotated and moved longitudinally through the biopsy needle 2.

On the distal side of the cogwheel 74 a tubular part 126 is connected to the threaded spindle with the boss 127 firmly. The tubular part is inserted into the support 36, the projection 127 being located accordingly on the distal side in front of the support. The length of the tubular part 126 corresponds approximately to the tensioning path, the wall thickness of the support 36 being further considered (see Figures 3a and 3b). The projection 127 moves in the case of the initial position of the instrument (closed sample extraction space) to the left, with respect to the distal side, while after opening the sample extraction space it reaches the support 36 (distal side) . In case of additional turns of the spindle sleeve with cutting device, that is, in case of trying to subsequently open the sample extraction space, the tension carriage is extended against the action of the short spiral spring towards the block 26, because the Highlight 127 is in contact on the distal side with the support

36. Because of this, the biopsy needle can be carried, as described below, in a forward and backward movement, which overlaps by a delimited angular rotation movement of the biopsy needle to both sides. This angular rotation movement is performed because the cutting sleeve tries to make the biopsy needle rotate together, however on the other hand it prevents the biopsy needle from rotating through a predetermined angular rotation, as the drawings especially show 12b -12d.

The gearwheel 74 on the left end of the threaded spindle combs after the incorporation of the biopsy needle holder in the tabs 40 with the toothed roller 23. In order to be able to incorporate the biopsy needle holder 37 in case of the tensioned carriage not tensioned (figure 2) on the tabs of the tension carriage, the biopsy needle holder has two flat, parallel recesses 77 (Figure 2). In case of placing the sliding surface of the biopsy needle holder 37 on surfaces 41, 42 and 44, the biopsy needle is simultaneously incorporated in the support 36 of the base block 8. On the left side of the cogwheel you can a plastic disc 78, which is provided with a light cone, is inserted to improve the spindle drive's ability to rotate, especially when the support 36 serves as a support for tensioning the tension carriage. In the case of the biopsy needle holder inserted correctly, the biopsy needle holder is slid, in case of tensioning of the tension carriage, with the sliding surface 43 on the surfaces 42 and 41 to the right. Since first, after the introduction of the biopsy needle holder, the sample extraction space is closed, the sprocket 74 is in contact with the support 36. If the toothed roller 23 is also actuated in the same direction , then the threaded spindle drive bolts the tension carriage to the right onto the biopsy needle holder until it is retained; In this regard, the biopsy needle is drawn inward, while the cutting sleeve remains in position. After retention, the cutting sleeve protrudes through the biopsy needle tip. Therefore, after retention of the tension carriage, the cutting sleeve is turned back to the starting position (opposite direction of rotation); the gearwheel 74 travels accordingly in the toothed roller from left to right. After unlocking the tensioning carriage, the biopsy needle / cutting sleeve with cogwheel slides back to the left with the biopsy needle holder. The cutting sleeve can now be moved back to the right to open the sample extraction space to

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which is pressed on the projection 127.

The function of the tension carriage positioned "floating" in connection with the drive motor that can be controlled and of the tubular part 126 connected to the cutting sleeve with the shoulder 127 is described in detail in relation to the development of the biopsy.

The right end of the cutting sleeve is connected through a sealing element 76 with the hollow biopsy needle in a mobile manner in rotation, but air tight, so that no air is introduced between the biopsy needle and the sleeve of cut that surrounds it coaxially, nor can air escape in case of overpressure. The sealing element 76 is composed of a flexible plastic tube that is dragged through the proximal end of the cutting sleeve. The internal diameter is selected so that it is easily disposed over the external diameter of the biopsy needle. In case of application of partial vacuum in the internal space of the biopsy needle and with it also between the biopsy needle (external side) and the cutting sleeve (internal side), the flexible elastic plastic tube is dragged against the external diameter of the biopsy needle. The flexible tube can then serve as a zeroing element (recoil spring), provided that the biopsy needle is rotated with respect to the cutting sleeve. To slightly rotate the biopsy needle by means of the cutting sleeve, the biopsy needle is slightly deformed in the area of the sealing element 76, so that it is oval at the deformed point 0, (see also Figure 12f). In case of rotation of the cutting sleeve, the biopsy needle is rotated together by deformation 0, and specifically until the rotation of the biopsy needle is limited by a stop (Figure 12b-12d).

This rotation angle movement of the biopsy needle has the consequence that simultaneously the sharp longitudinal edges of the biopsy needle space deviate around the longitudinal axis of the biopsy needle to both sides. Since this rotation angle movement is performed by the same drive and simultaneously with the forward / backward movement of the biopsy needle, the cutting edges of the sample extraction space cut the tissue according to the type of blade driven both longitudinally to the X axis as simultaneously with angular rotation, so that the tissue under pressure (external and / or internal pressure) is safely inserted into the open sample extraction space. Figure 12f shows the position of the sample extraction space in the neutral initial position after opening; Figure 12g shows the position after an angular rotation in the angle α to the right and the simultaneous backward movement of the biopsy needle in the magnitude X1 (approximately 2 mm) towards the proximal side; Figure 12h shows the position of the biopsy needle in case of a left turn at the angle β and the simultaneous movement of the biopsy needle towards the distal side in the magnitude X2 (approximately 2 mm). By moving the cutting edges of the sample extraction space, or the biopsy needle, it is guaranteed that the tissue is cut in each case at the longitudinal edges, regardless of the tissue structure. The described movement of the biopsy needle and with it the sharp longitudinal edges of the sample extraction space also leads to the cut tissue part being introduced into the sample extraction space also when the pressure normally applied is not present.

At the right end of the biopsy needle 2, a round plastic piece 47, also hollow and connected in force drag with the biopsy needle, is placed tightly in the air. The plastic part 47 has on its left end a support element 49 which is snapped into the biopsy needle holder; at its right end protruding from the handpiece, another plastic part 112 is incorporated which can be rotated with respect to the plastic part 47 and with respect to the biopsy needle 2. Between the biopsy needle and the plastic part 112 an O-ring is incorporated for sealing. The plastic part has at its right end a pin 17, in which the connecting element 4 is placed slidably air tight. Also on the right side protruding from the biopsy needle holder and the housing, there is a knurled disc 80 with which it can be adjusted radially by rotating the position of the sample extraction space without changing the position of the cutting sleeve. With a rotation of the biopsy needle, only one rotation of the sample extraction space is associated. The plastic part 47 with the biopsy needle and the cutting sleeve snap into place with the support member 49 and the threaded spindle nut 75 in the biopsy needle holder. The biopsy needle is placed through the support member 49 and its narrow guide in the cutting sleeve movably rotatable in the biopsy needle holder and in the cutting sleeve and can be moved with the biopsy needle holder in the longitudinal axis. As described above, the cutting sleeve can be moved axially by rotating with respect to the biopsy needle.

To the right of the support element 49, a multiple edge 50 is disposed on the plastic part 47 that can be retained with the biopsy needle holder 37 by tensioning, so that the sample extraction space of the needle can be carried biopsies by means of the knurled disc 80 to the favorable position for the extraction of the biopsy and keep it in it. In case of rotation, the two sides 39 of the biopsy needle holder, which is composed of an elastic plastic, widen at the corners of the multiple edge until the surfaces of the multiple edge meet again almost perpendicular to the sides 39 and therefore the multiple edge is retained again (see especially Figure 12c). The multiple border is subsequently adjusted to a predetermined degree. If in the case of the multiple edge it is a hexagon, then the rotation of approximately 60 ° is performed; if it is intended to have more degrees of rotation, then a multiple edge with 8, 10 etc. is correspondingly selected. degrees.

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As especially shown in Figures 12b -12f, the biopsy needle holder has two sides 39, which are joined together through a crossbar 116. In the plastic holder it is positioned so that the multiple edge 50 of the plastic part, in which the sides 39 joined with the elastic cross member widen in the case of first turning outwards to then return again, by elasticity, to their starting position. If a key width S is now selected for the multiple edge, which is smaller than the distance A (inner width) of the two sides of each other, then the biopsy needle can be turned slightly to both sides around its axis in an angle (α or β) previously determined to the right and left around the longitudinal axis in a limited manner (figure 12b and figure 12d, figure 12c shows the central position). The sides 39 of the biopsy needle holder do not widen accordingly; on the contrary they prevent the biopsy needle from rotating at a greater angle, since the drive is configured so that the cutting sleeve can rotate even more, however the resistance of the limitation of the sides is greater than the moment drive. The corners of the multiple edge therefore touch the sides 39 and prevent an additional rotation, because the moment of rotation acting on the biopsy needle is not sufficient for a widening of the two sides. Since the plastic part 47 with the multiple edge is firmly connected with the needle and the cutting sleeve slid, in the case of the open sample extraction space, in the deformed area 0 of the biopsy needle, and finally also the sealing element 76 on the outer side of the biopsy needle, in case of the open sample extraction space, acquires a friction joint in some way, the biopsy needle is rotated by this friction joint around its axis , in the case of actuation of the cutting sleeve, in each case the direction of rotation, until the stop of the multiple edge prevents an additional rotation (in the absence of a greater turning moment). Since the elastic sealing element is dragged in this phase in a reinforced manner by the partial vacuum prevailing against the external surface of the biopsy needle, this causes the element to rotate with respect to the biopsy needle the element of shutter it favors on the one hand the turn; on the other hand it acts as a zeroing element whenever it comes into contact slightly. That limited turning movement is understood as angular turning movement. The biopsy needle that can rotate in a limited way returns to its starting position from the angular rotation movement by modifying the direction of rotation and as a consequence of the twisted sealing element to then rotate again in the other direction against the action of the elastic sealing element. For limited angular rotation movement in relation to forward / backward movement, as described below, approximately one revolution of the gearwheel 74 in each direction is generally sufficient (respectively approximately one revolution from the position zero). In the case of a rotation movement of the cogwheel, the biopsy needle is moved approximately 2 mm to the left or right from the zero position and moves simultaneously at the angle α or β around the longitudinal axis. In general, this movement path is repeated in each direction approximately 5 times.

As especially shown in Fig. 12, the cutting sleeve that coaxially surrounds the biopsy needle is connected through the threaded spindle nut 75 with the biopsy needle holder 37. In the threaded spindle nut 75 is placed The threaded spindle sleeve 73 is rotatably rotated. A rotation of the gearwheel 74 by the drive motor of the toothed roller 23 causes the biopsy needle holder and tension carriage to move to the right as soon as the gearwheel 74 is tighten on the support 36. In the case of a position of the gearwheel within the length of the toothed roller 74, that is, provided that the gearwheel is free and is not in contact with the support or with the threaded spindle nut 75, the cutting sleeve can be adjusted only, so that for example after tensioning the biopsy needle to compensate for the tip of the needle and the cutting sleeve to redirect the cutting sleeve to the starting position or to open and close the sample extraction space.

In case of the opening of the sample extraction space, the cutting sleeve moves through the slightly deformed zone 0 of the biopsy needle. In this position, in case of additional rotation of the cutting sleeve, the biopsy needle is drawn together in the direction of rotation at a predetermined angle; Since, however, the cutting sleeve / biopsy needle joint only allows the transfer of a predetermined turning moment, the rotation movement of the biopsy needle stops when the corresponding corners of the multiple edge are pressed on the sides of the support of biopsy needle (see figures 12b or 12d).

The tubular piece 126 placed on the distal side of the toothed wheel with projection 127, which interacts with the support 36, serves to move the needle in cooperation with the control in a short vibration movement (forward and backward movement) and simultaneously , as described, to move the biopsy needle in a changing angular rotation movement.

Since the vibration movement (forward and backward movement) is performed through the drive for the cutting sleeve 3, simultaneously through the joint of the cutting sleeve with the deformed "0" position of the biopsy needle and by means of the configuration of the multiple edge 50 as well as the biopsy support part, a limited rotation of the biopsy needle is made towards both directions of rotation (in each case towards the direction of rotation), which overlap the movement forward / towards behind the biopsy needle. Through these two common movements, each type of tissue is cut through the cutting edges of the sample extraction space. The removal or deposition of the tissue in the sample extraction space is obtained reliably also in case of hard tissue or provided with inclusions and / or pressure. The aforementioned forward / vibration movement of the biopsy needle (forward and backward movement), which also generates the

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angular rotation movement, described below:

In case of driving the toothed roller, the sample extraction space is opened through the gearwheel 74 until the projection is pressed on the support 36 on the distal side. If the same direction of rotation is now maintained, and the sprocket is not in contact with the threaded spindle nut, then the additional rotation causes the tension carriage to drag through the biopsy needle holder towards block 26 against the short coil spring action, since an additional opening of the cutting sleeve is not possible while the shoulder 127 is in contact with the distal side of the support 36. The tensioning path or the movement path (X1 or X2) amounts to approximately 2 mm or corresponds to approximately 1 revolution of the cutting sleeve. With the stop of the gearwheel 74 on the threaded spindle nut, the direction of rotation of the motor is reversed and with the short spiral spring back, the tension carriage is moved back to its starting position (rest position), turning towards back the biopsy needle to its zero position. Since a transducer counts the number of revolutions of the motor, and the real values are deposited in a programmable microprocessor, through the corresponding specifications, the direction of rotation of the motor can be changed according to the specifications, so that the tension carriage is dragged again against the block or is redirected towards unlocking. By means of the continuous revolution of the direction of rotation of the motor, according to the specification, in cooperation with the tensioning and unlocking of the carriage, the biopsy needle makes a forward / backward movement, which to be superimposed by a limited angular rotation movement of the biopsy needle to both sides according to the direction of rotation in each case. In general, five forward / backward movements are sufficient to ensure good sample extraction also in case of hard and / or viscous tissue or tissue with inclusions, for example lime. By moving back and forth in relation to the limited angular rotation movement of the biopsy needle and the sharp cutting edges, the tissue is separated, which is drawn for example by vacuum to the sample extraction space, at the edges lateral, to allow and facilitate considerably the introduction of the sample also in case of hard tissue in the sample extraction space.

The described movement of the biopsy needle and with it the sharp longitudinal edges of the sample extraction space allows optimal tissue cutting after opening or during the opening of the sample extraction space. The same good action of the cut of the fabric is also achieved when already during the opening, that is, with the reconduction of the cutting sleeve, this vibration movement or angular rotation movement is generated.

In figures 12g -12f this superimposed movement of the biopsy needle space is shown again in detail in the left and right turn phases as well as the zero position. Figure 12g shows among other things the starting position; The biopsy needle space is open, the cutting sleeve is approximately 2 mm retracted through the proximal edge of the sample extraction space, the multiple edge is in neutral position (Figure 12c). In the case of the representation in figure 12h and figure 12g the biopsy needle is redirected in the cutting sleeve and simultaneously the needle rotates at the angle α. Figure 12f and Figure 12d show the other direction of rotation and the rotation at angle β. The proximal edge of the biopsy needle space travels approximately 2 mm to the distal side with respect to the initial position and simultaneously rotates at the angle β in the other direction. Figures 12g -12f and Figures 12b -12d show a cycle that is repeated several times according to the microprocessor control in each case, as a rule they are 5 cycles. This forward / backward movement and limited angular rotation movement can also be generated through electrical elements that are connected with the needle or the tension carriage.

Certain details with respect to the sample extraction space as well as with respect to the configuration of the biopsy needle tip are shown in Figures 11a-11g. The sample extraction space 71 connected to the tip of the needle 70 is open upwards approximately more than 25% of its cross section. Thus, in case of an external diameter of the biopsy needle of 3.3 mm, the height H of the sample extraction space is approximately 2.3 mm. The sample extraction space is approximately 15 to 25 mm long. The hollow space of the biopsy needle is attached to it. In the transition, that is, at the proximal end of the sample extraction space, the cross section of the hollow space of the biopsy needle is closed between 50% and 75% by a narrowing, for example a cap 79 (Figures 11b -11e). The height of the cap is designed so that it reaches down through the recess for the sample extraction space. As Figure 11e shows, at the base of the sample extraction space is an opening F from the height of 0.6 mm in case of an internal needle diameter of 3.0 mm. The vacuum due primarily to the tissue sample with the continuous opening of the sample extraction space must be removed in the sample extraction space down and reach the wall of the sample extraction space. In case of overpressure in the hollow space of the biopsy needle, the narrowing, the cap, acts so that the pressure increases. The plug is approximately 10 mm long and is glued or welded in the hollow space. In the case of laser welding it has been shown that it is advantageous to configure the left side of the cap thinly by removing material from the front surface in a short length, approximately 2 mm. As a result, the biopsy needle tube with the front side of the cap is fully welded in this area on the front surface and is air tight on the front side. The plug may also have a shorter length, provided that the same action is obtained. In this way the cap can also be replaced by a lip or drag stop of approximately the same height. It is important that the narrowing is configured so that the vacuum in the sample extraction space has an effect on everything from the base, so that the sample adheres in case of the closing of the cutting sleeve, that is in the case of the cutting process , to

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the wall of the sample extraction space and do not change its position. It has also been advantageous to provide additional fixing means in the sample extraction wall. By sucking the sample from below in the sample extraction space, a high degree of filling of the sample extraction space results on the one hand and, on the other hand, especially through its configuration, a good fixation of the sample to the wall . For this reason it is important that the lateral cutting of the tissue by the described movement of the sharp longitudinal edges of the sample extraction space guarantees an introduction of the tissue to the base. Since the cutting sleeve separates the sample on the outer side of the biopsy needle, this adhesion of the sample remains on the inner side if possible also with the separation process. By means of the cutting sleeve arranged on the outside and the tissue adhered to the internal base of the sample extraction space, the sample itself neither rotates nor twists in the case of the closing process by means of the rotary longitudinal movement of the cutting sleeve. Because of this, the quality of the sample is considerably improved, than in the case of the torsion-like arrangement. The pathologist obtains a starting material, which in cross section corresponds to the section in the tissue and not a mixture of twisted or deformed tissue. Ejection of the pressure sample in a safe way of deposition. This is facilitated by the cap 79. Additionally, a complete purification of the sample extraction space takes place, so that in case of repeated biopsy, no mixing of tissue samples (residual particles) takes place. Since the vacuum generating device is used simultaneously as a pressure generating device, the entire hollow space is purified, especially the biopsy needle in case of ejection. In case of normal tissue it is sufficient to use the wall thickness of the biopsy needle tube of approximately 0.15 mm as the lateral cutting edge. In the case of hard and / or compact fabric, the degree of filling in the sample extraction space is not sufficient only by suction by means of vacuum, since the tissue at the lateral edges is not sufficiently separated. Due to the configuration of the longitudinal sides of the sample extraction space 71 with respect to the cutting edges 68, as shown in particular in Figure 11g and Figure 11f, by superimposing a forward / backward movement several times and a angular rotation movement several times, limited from the biopsy needle with the sample extraction space to the left and right (as described) as well as by the pressure effect, for example by internal vacuum, the tissue is cut of the sample on the longitudinal side, so that the sample moves considerably better towards the base of the sample extraction space by means of vacuum or external pressure. By applying an external pressure or an internal vacuum, for example by means of the ultrasound probe or a vacuum in the hollow space of the biopsy needle, the cutting action of the longitudinal edges can be reinforced. By cutting the sectional surfaces on the longitudinal side of the tissue sample to be extracted, an excellent degree of filling is also obtained in the case of hard and / or viscous tissue or tissue with inclusions by the movement of the needle. In this way tissue material is prepared sufficiently for study. The cutting edge on the longitudinal side of the sample extraction device is configured so that the partial part (T1) is removed by milling the wall thickness (Figure 11g). The diameter (ra) of the external contour of the biopsy needle tube remains, while the internal diameter (ri) of the internal contour is transformed, for example, by milling the partial piece (T1) through a perpendicular wall in the external contour (see figure 11g).

Figure 11d shows the closed sample extraction space in which the extracted sample is located. In the case of the separation process, it has been advantageous to move the cutting sleeve 78 through its final position shown in Figure 11d in a distal direction approximately 2 mm and then to redirect the cutting sleeve in these 2 mm to its final position. This shearing effect reliably separates fibers that are not yet separated, which leads to a further improvement in the quality of the samples.

The biopsy needle described in this document works with vacuum applied in the internal space. Forward / backward movement combined with limited angular rotation movement, overlapping of the biopsy needle and thereby cutting the sample extraction space leads to excellent results also in case of biopsy needles without vacuum or in case of loss of vacuum, especially when, for example, instead of the internal vacuum in the hollow biopsy needle, external pressure is applied to the tissue, for example, by ultrasound. However, the unique application of the angular rotation movement, which is superimposed on the forward / backward movement of the needle in relation to the longitudinal edges of the sample extraction space configured as blades, considerably improves the process of tissue cutting and It facilitates the introduction of the tissue sample to be removed in the sample extraction space.

It should also be added that the elastic sealing element is not necessary at home as a zeroing element, and zeroing can also be carried out only by reversing the direction of rotation.

Figure 13 shows the actuation and assembly of the vacuum / pressure generating device 5 (viewed from the rear, that is to say contrary to the Z axis, the housing cover and the lower part of the housing are omitted).

In the upper, rear, right area, the vacuum / pressure generating device 5 is arranged as a piston / cylinder unit 69. This is constituted by an injection body 52 with threaded spindle 53 disposed therein, at the end of which The injection base 51 is fixed to a piston 54 with sealing elements (as is generally known in the case of injection) (Figures 14a-14d).

At the end directed to the base block 8 of the injection body 52 a nut is arranged in the threaded spindle

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threaded spindle 48 with gearwheel 55 configured on the periphery. The threaded spindle nut has one or more thread turns. The threaded spindle 53 interacts with the threaded spindle nut 48. The spindle has a slope of approximately 5 mm per thread turn, so that in case of each revolution of the plunger by means of the spindle drive it moves in a defined magnitude of precise way outside the injection body, that is outside the injection base 51, or towards the injection base, in each case the direction of rotation. The toothed crown 55 disposed on the periphery of the threaded spindle nut combs with the driven pinion 56, which is fixed on the secondary axis of the DC motor 58. The secondary axis of the DC motor 58 is placed in the base block 8; for this, the power take-off shaft is inserted in the transverse plate 59 of the base block. If the DC motor 58 is activated, then the piston is moved according to each direction of rotation with respect to the injection base or towards the base block 8. A DC motor with a high number of motors is also used as the drive motor. revolutions, to which a planetary gear with high reduction is subsequently connected. This corresponds to the motor already described for the tensioning device. In the DC motor, a counting device is therefore fixed on the distal side which is constituted by a two-arm helical wheel 131 and a photocell mounted 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 through the number of revolutions, being able to consult the functions after determining a starting value by means of programmable or programmed specifications.

Plunger 54 is configured in a manner known as injection plunger. The injection body made of plastic, a cylinder with base, is transparent.

To prevent rotation of the threaded spindle 53 in case of actuation of the threaded spindle nut, the two opposite surfaces 60 of the threaded spindle are flatly configured (Figure 14d). The threaded spindle is inserted with the free end into the insertion element. The distance of the surfaces of the threaded spindle corresponds to the width of the U-shaped insertion element 62 of the base block 8. Between the U-shaped cross section of the introduction element and the spindle surfaces on both sides there is only one gap reduced. The threaded spindle nut rests on the base block.

In order to prevent sliding out of the injection body 52 in the event of rotation of the threaded spindle nut, the contact surface is configured in the base block 8 in a slightly conical manner downwards.

The connection tube 63 of the injection body 52 is inserted in step 16 of the end cover of the housing 7, so that the injection body is held approximately horizontally.

To rotate the smooth-running threaded spindle, the threaded spindle nut with toothed crown on the side facing the base block has a strong chamfer 66 of approximately 1.5 mm. Since in addition the surface of the rib 59 in 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 dragged down in case of operation . To generate a sufficient vacuum of approximately 200 hph in the sample extraction space it is used, for example in case of a biopsy needle length of approximately 250 mm and an internal diameter of the hollow biopsy needle between 3 and 5 mm, an injection body for 20 ml with a length of approximately 90 mm. In order to be able to use the injection body also as a pressure generator, approximately ¾ of the length, corresponding to the stroke of the piston for the generation of vacuum (position according to figure 11b), a ventilation hole 67 of approximately 1 is provided, 5mm in diameter The ventilation hole can also be configured as an elongated hole. If the injection piston moves out through the vent hole 67 (Figure 14c), (when vacuum is no longer needed), the vacuum generated previously in the hollow biopsy needle is removed by feeding air (atmospheric pressure) through the vent hole 67. If the direction of rotation of the gear motor is then reversed, then an overpressure is generated in the system by entering the plunger (towards the injection base) in the vacuum / pressure generating device , which causes the ejection of the tissue sample after opening the sample extraction space. In order to prevent tissue fluid from flowing out of the ventilation opening 67, the ventilation opening may, for example, be covered with an air permeable sponge (not shown). A delayed connection, which is integrated in the control, prevents ejection of the tissue sample by mistake by pressing the programming key 89, since this delayed connection does not activate the process until the pressure of approximately 1.2 -1 , 5 s. The ejection of the sample should not be performed until the needle biopsy is removed from the tissue, which is guaranteed in this way. Otherwise, not only the sample extraction space, but also the internal space of the biopsy needle, is purified by compressed air. Using the cap that narrows the hollow space of the needle makes it difficult or very difficult to introduce tissue parts into the hollow space of the biopsy needle. By narrowing the hollow space of the needle by means of the cap 79, the pressure in the sample extraction space is increased and due to this the ejection of the sample is improved just in case of the semi-open sample extraction space. In case of using the vacuum biopsy instrument it is recommended to use a specially configured coaxial cannula that is adapted to the requirements and needs of the instrument. This must contain corresponding devices that prevent an entry of air and hinders or eliminates the outflow of tissue fluid; on the other hand it must be easily inserted into the tissue.

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The operation of the biopsy device is explained in more detail below:

The following stages of development can be distinguished, which largely take place automatically according to their respective introduction:

a) Start and adjust the initial position b) Tension of the biopsy needle and tissue injection c) Removal of the tissue sample (sample extraction) d) Extraction of the sample after the closed biopsy needle has been removed from the tissue.

a) Start and adjust the initial position

The insertion element 20 that can be removed, constituted by the vacuum / pressure generating device, the elastic joint element as well as the biopsy needle holder with needle and cutting sleeve and other elements associated therewith, as well as a roller guide 81 placed on the needle, supplied sterile packed. The elements that can be removed (see Figure 2) are held by an auxiliary means of introduction that is removed after insertion into the handpiece. This auxiliary insertion means 104 has two clamping pieces for the grip on the upper side as well as tabs 108 for clamping the biopsy needle holder 37 and the vacuum / pressure generating device. For fixing the position of the vacuum / pressure generating device (in parallel with the biopsy needle holder), a pin 110 for tongue retention is provided, which is inserted into the vent hole.

The piston 54 in the injection body 52 is removed, in case of supply, slightly (1-2 mm) from the injection base, the sample extraction space 71 of the biopsy needle 2 is open to be able to perform from that mode before the introduction a visual review of the sample extraction space. After opening the housing cover 10, the biopsy needle holder is introduced, including the biopsy needle 2, the cutting device 3 and other parts associated therewith, such as the connected vacuum / pressure generating device 5 with the connection element 4, in the connection elements provided in the handpiece (see figure 2). In the case of the introduction process, attention must be paid to the fact that the sprocket 74 engages the teeth of the toothed roller 23; the cutting sleeve is inserted from above into the U-shaped support 36, simultaneously the tabs 40 of the tension carriage are inserted into the recesses 77 of the support element; the guide roller 81 is introduced in step 13, so that the flanks 101 and 102 comprise the end cover of the housing 6. The cutting sleeve can slide longitudinally in the guide roller and is rotatably positioned freely; however, the guide roller itself can no longer slide with respect to the cutting sleeve after insertion into the end cover of the housing. The vacuum / pressure generating device is then introduced on the one hand in the insertion element 62 open upwards of the base block 8 with the end 61 free and on the other hand in the U-shaped step 16, opened upwards with the connecting tube 63. The connecting tube 63 is located above the actuation bolt 19. Since the insertion element on the side of the base block has an internal width that precisely allows the introduction of the threaded spindle provided on both sides of surfaces 60, the threaded spindle is secured in the insertion element securely against rotation. The gear ring 55 of the threaded spindle nut 48 engages after insertion into the driven pinion 56 of the gear motor. The distance between the base block on one side and the end cover of the housing 7 on the other hand is maintained such that the injection body 52 is precisely accommodated with the threaded spindle nut 48 placed in the injection body. The injection body and cogwheel unit positioned is held in such a way that it cannot move axially. After introduction, the vacuum / pressure generating device is parallel to the biopsy needle holder; the connecting element 4 describes a curvature of approximately 180 °. It should be added that the introduction is made in the case of the tensioned carriage not tensioned; This means that the cogwheel 74 in case of the open sample extraction space meshes on the right end of the cogged roller (Figure 3). After the correct introduction, the housing cover can be closed.

To facilitate the introduction process, the described auxiliary introduction means can be used. However, the introduction can also be carried out without auxiliary means of introduction. With the closure of the housing cover, the connecting tube 63 is pressed downwards and in this respect, the microswitch is activated by means of the actuation bolt 19 mounted on the housing end cover. As a result, the electrical system is activated, which is indicated by the flashing of the resume diode (yellow) 91 on the front of the handpiece. The resume diode flashes yellow, which means that the placement of the individual elements, that is the introduction process, is not yet finished; The DC motor 21 must also close the sample extraction space 71 with the cutting sleeve 3 (the sample extraction space was partially opened in case of introduction). This is produced by turning the threaded sleeve connected with the cutting sleeve. The cutting sleeve moves to the left until the sprocket 74 arrives near the inner side of the support 36. The plastic disc 78 is in contact, after the closure of the sample extraction space, with the support 36 (internal side ). The DC motor 58 contacts this injection or before or after the injection piston 54 with the injection base 51. In this phase the counter of the microprocessor is also set to zero for the movement of the biopsy needle unit / cutting sleeve and vacuum / pressure generating device. From this basic setting, the programmed movement paths are made through the counting device provided in the two motors.

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After reaching the starting positions for the vacuum / pressure generating device and the biopsy needle / cutting sleeve unit, the tension diode 94 (yellow) and the sample extraction diode 92 (green) are illuminated, turning off the resume diode.

b) Tension of the biopsy needle and injection of the biopsy needle into the tissue

The operator must decide at this stage if he starts tensioning the tension car or wants to extract other samples, for example after a tissue sample has already been removed. In the case of the extraction of a first tissue sample, the operator presses the tensioning key 90. This starts the tensioning of the tension car; the tensioning diode flashes yellow, turning off in the sample extraction diode (green) 92. Pressing the tensioning key (due to the delayed connection the key must be pressed approximately 1.2-1.5 seconds) the gearmotor Electric current 21 obtains current and the DC motor drives the toothed roller 23. The toothed wheel 74 that combs with the toothed roller 23 rotates the spindle shaft and simultaneously the cutting sleeve 3 connected therewith. Since the spindle nut 75 is snapped into the biopsy needle holder 37 and the cogwheel 74 is supported through the plastic disk 78 in the holder 36, which is firmly attached through the base block with the housing, the rotation of the threaded spindle sleeve 73 causes the biopsy needle holder to move to the right. Simultaneously, the biopsy needle 2 connected with the biopsy needle holder is dragged along the support element 49, which leads to the tip of the biopsy needle moving towards the cutting sleeve. The biopsy needle holder 37 travels through the recess / tongue joint of the tension carriage against the action of the spiral spring 31 to the right until the lever 33 of the retention element is pressed into the recess 82 of the tension carriage by means of spring 34. The tension carriage is locked in this position. The geared motor obtains the control instruction that the blocking position has been reached, for example through a photocell embedded in the sliding surface of the cover plate, which interacts with the biopsied needle holder; or through the microprocessor that compares on the one hand the real number of revolutions with the theoretical number given that it was previously programmed; the direction of rotation of the motor is reversed after reaching the theoretical value and the cutting sleeve is turned backwards to the right in the magnitude in which the cutting sleeve was moved by moving the tension carriage and the biopsy needle through from the tip of the biopsy needle out. At the end of this stage, the cutting sleeve closes the sample extraction space completely (figure 11d), such as at the beginning of the tensioning process. The blocking diode 95 lights green; the flashing of the tensioning diode 94 goes out. In order to reduce, in the case of the tensioning process, the frictional force between the gearwheel and the support element, for example, an additional plastic disk 78 is arranged between the gearwheel 74 and the support 36.

The biopsy needle of the biopsy device is now incorporated, for example, in a previously placed coaxial cannula. The proximal end of the placed coaxial cannula contains a seal, which is sized so that on one side the space between the cutting sleeve and the cannula is sealed, on the other hand it allows a slight introduction of the biopsy needle with a cutting sleeve. The sealing ring prevents air from being drawn from outside through the space between the cannula and the cutting sleeve. Similarly, the sealing ring prevents an outflow of fluid (cytological material) after the introduction or injection of the biopsy needle. This almost avoids 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 handpiece from the cannula. The tip of the biopsy needle approaches the tumor by removing the dome in the coaxial cannula and is included in the tumor after proper placement.

Triggering is activated by pressing the actuation key 88. The pressure has the consequence that the tension carriage is unlocked by rotating the double-arm lever 33 around the axis 35. The tension carriage is thrown to the left by means of the spring action. The microprocessor is informed of the activation of the trip and the new position of the water by, for example, an integrated photocell. The sample extraction diode illuminates green, the yellow tensioning diode illuminates.

c) Removal of the tissue sample

Pressing the programming key 89 again unlocks the development for the extraction of samples; the sample extraction diode 92 flashes green. First, the DC motor 58 of the vacuum / pressure generating device is activated. The plunger of the vacuum / pressure generating device moves towards the base block, that is, moving away from the injection base, until it reaches a position shortly before unlocking the vent hole 67 (Figure 14b). The vacuum is generated in the system. After reaching a final position, the system activates the motor 21, the cutting sleeve that closes the sample extraction space is opened through the cogwheel / spindle drive. During the opening process, the tissue and the eventual cytological fluid (cytological material) must be suctioned or pressed by means of the partial vacuum prevailing in the system or a pressure applied from the outside in the sample extraction space. The cytological fluid is flowed among other things by vacuum in the hollow space of the biopsy needle and in the vacuum / pressure generating device. It has been advantageous that by means of the stopper (79) the partial vacuum is directed mainly in the lower area, the lower side, of the sample extraction space and by means of the stopper 79, the introduction of the tissue into the hollow needle is hindered or prevented of biopsies. After the complete opening of the sample extraction space or during the opening the biopsy needle moves back and forth

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briefly, approximately 5 times, in the area of approximately 2 mm. With this movement, that is simultaneously, an angular rotation movement of the biopsy needle and with it the sample extraction space around the longitudinal axis is connected in a preferred embodiment. This is done because, through the drive motor 21, in the case of the completely open sample extraction space, the drive motor obtains the instruction of the microprocessor to subsequently open the sample extraction space; however, this is not possible, since the projection 127 prevents a subsequent displacement of the cutting sleeve to the right

Through the threaded spindle / threaded spindle nut joint and the biopsy needle support element the tension carriage is moved towards the distal by approximately 2 mm and in this respect the short spiral spring is compressed. By controlling the microprocessor the direction of rotation of the drive motor is changed after a predetermined number of revolutions, corresponding to the 2 mm travel. The tension carriage is brought back by the spiral spring and the motor to its starting position. Then the drive motor is changed again and the tension carriage is dragged again against the action of the short spiral spring; after reaching the tensioning path, the change of direction and so on is made. This forward / backward movement and the angular rotation connected therewith of the biopsy needle lead to the tissue being cut by the longitudinal edges of the sample extraction space and consequently the introduction of the sample into the space is ensured. Sample extraction also in case of difficult tissue. The process can be repeated arbitrarily frequently, depending on the programming in each case. In general, 5 cycles are sufficient to use the sharp longitudinal sides of the sample extraction space by means of this movement control so that, also in the case of hard tissue samples or tissue with inclusions by cutting the laterally located tissue, the sample of tissue can be introduced into the sample extraction space slightly and completely, for example by means of vacuum.

At this point it is insisted again that the tissue separation process in the simplest case can also be carried out by exclusive forward and backward movements of the biopsy needle, especially when an external pressure is applied, for example by means of ultrasound . The additional turning movement around the longitudinal axis of the needle can optionally be carried out by correspondingly providing for this purpose necessary measures, explained above, which advantageously support the tissue separation process.

After the movement of the combined biopsy needle described above as advantageous, the direction of the geared motor 21 is changed and the sample extraction space 39 is closed by rotating the cutting sleeve, separating the cutting edge 72 of the cutting sleeve 3 the tissue in case of the closing process. It is evident that by means of the corresponding constructive modification or the corresponding control as well as additional elements the forward / backward movement, or the angular rotation movement of the biopsy needle can be performed for the cutting of the lateral sample edges also during the opening of the cutting sleeve. In the case of the closing process, the cutting sleeve is advanced from its closed position, approximately 2 mm, towards the tip of the needle additionally. Because of this, the tissue fibers are separated safely. The cutting sleeve is then redirected approximately 2 mm to the closed position.

Process control is carried out by the microprocessor, in which the theoretical values are deposited and which compares the microprocessor with the measured data (measurements) and thereby controls the processes. By means of the special configuration of the sample extraction space and also as a result of a vacuum that is applied, the tissue sample is safely maintained against the rotation in the sample extraction space, so that by means of the cutting sleeve 3 that can be Rotating longitudinally, which surrounds the biopsy needle externally, does not rotate or twist the tissue sample, as described. After the sample extraction space has been closed, the DC motor for the vacuum generating unit 5 is activated. The piston 54 is first redirected until the piston unlocks the vent hole (Figure 11c) . After the suppression of the vacuum in the system, the piston is advanced towards the injection base until the ventilation opening is closed again, to prevent the outflow of body fluid (cytological fluid). This brief opening of the ventilation hole is in the range of fractions of a second to avoid as much as possible that the fluid can escape into the handpiece. To prevent the fluid from reaching through the ventilation hole or the ventilation holes to the handpiece, the ventilation holes may be covered, for safety reasons, additionally with air-permeable material, so that the internal space of the handpiece. The flashing of the sample extraction diode 92 goes out. Triggering diode 93 lights yellow. The biopsy needle with the closed sample space is dragged through the cannula.

d) Extraction of the sample after the tissue biopsy needle has been removed

After removing the biopsy needle from the tissue and preparing a container for housing the tissue sample and tissue fluid, the programming key 89 is pressed again and the ejection diode 93 begins to flash. Due to the delayed connection, for security reasons, the programming key must be pressed approximately 1.2-1.5 seconds before development begins. First, the gearmotor 21 of the cutting sleeve is operated to open approximately half the sample extraction space. Then the DC motor 58 of the vacuum / pressure generating device is activated. The direction of rotation of

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DC motor 58 is maintained and the threaded spindle 53 with piston moves towards the injection base, so that only an overpressure occurs in the system. The plunger is advanced to the base of the plunger, the drive motor 58 being deactivated. The geared motor 21 redirects the cutting sleeve through the sample extraction space subsequently, after the piston has reached the base of the plunger. As a result of the overpressure applied in the system, the sample is pressed out under pressure, even in case of the semi-open sample extraction space in an available laboratory vessel, the hollow space, vacuum / pressure generating device, is simultaneously released. the biopsy needle and the space for extracting samples of tissue and fluid particles. Therefore, the ejection of the sample in the case of the approximately semi-open sample extraction space is performed because due to this the ejection of a tissue sample is guaranteed and the tissue sample does not fall into the sample extraction space by means of the premature suppression of overpressure. The narrowing of the hollow space of the biopsy needle by means of the cap 79, which has hindered or prevented the introduction of tissue into the hollow space of the biopsy needle, is especially advantageous in the case of sample extraction, since the cross section narrowing increases the ejection pressure. The best ejection results were achieved in case of semi-open sample extraction space; that is, the cutting sleeve unlocks half of the axial length of the sample extraction space. The tissue fluid from the sample extraction space is also pressed by overpressure and the sample is cleaned.

After the sample extraction space has been completely opened, the extraction and cleaning is finished, the ejection diode is turned off. Resume diode 91 lights yellow. As long as no additional sample has to be extracted now, the housing cover opens and the element 20 that can be removed is removed. In case of opening the cover of the housing 10, the system is deactivated by the microswitch 18. If, however, another sample of the same tissue environment is to be removed, then the operator presses the programming key 89 and the resumption diode 91 begins to to blink. The initial adjustment of the vacuum / pressure generating device takes place again as the cutting sleeve, as described. After completion of the process, the resumption diode 91 is extinguished and the sample extraction diode (green) and the tension diode (yellow) are illuminated. It now resides in the operator if you want to remove only a sample of additional tissue from the same impact hole (in this case press programming key 89) or if you want another impact by tensioning the biopsy needle (in this case press tensioning key 90). Depending on the choice in each case, the additional steps of the procedure are developed in the sequence already described. The process can be repeated arbitrarily frequently. The operator must decide after ejection of the sample only if he wants to extract another sample or the sample extraction is finished and the housing cover is opened.

It should be necessary for the sample to be extracted at a point of the tumor that, after the impact, is not directly on or in the sample extraction space, that is for example laterally, so that the position of the extraction space can be rotated of samples 71 through knurled screw 80. So that the operator can recognize this radial position of the sample extraction space, a marking in the form of a notch 119 is placed on the knurled screw, which is shown upwards when the opening of the Sample extraction space is shown up. In the adjusted position respectively, the biopsy needle is fixed by means of the multi-edge surfaces 50 and the elastic forces on the support part. The sample extraction process is the same as already described.

After the completion of the biopsy, after unlocking the cover, the exchangeable element 20 (vacuum / pressure device, biopsy needle / cutting device with all the elements arranged therein) is removed upwards. In order to prevent an opening of the housing in case of the tensioned tension carriage, a safety wing 84 is disposed in the biopsy needle holder which in the tensioned state is in contact with the left front surface 85 of the closing device. The closing device that can move on the X-axis can no longer move to the left in the open position, and with it, the trailing stop 12 of the recess 45 can no longer be removed. the housing cover, provided that the element that can be removed in the tension car already prestressed has been introduced, since the safety wing prevents the latch from being introduced into the space provided for it. The surface 85 of the latch collides with the safety wing. The battery charging diode 96 is disconnected as soon as the housing cover is opened. In the case of the closed cover and the insertion element 20 inserted, the battery charging diode indicates whether sufficient power is present.

Basically it is conceivable that all the stages for the extraction of a sample as well as the tensioning of the car and so on are controlled by activating and deactivating the two gearmotors individually by hand. However, it is convenient to include the individual stages of the development process and develop automatically and only start the next stage by operating the switch. This semi-automatic procedure, as described above, has been especially advantageous.

Basically, two procedures are conceivable to detect the actual values for comparison with the theoretical values. One procedure is based on the measurement of the longitudinal displacement of the threaded spindle in case of extraction or introduction under pressure as well as the measurement of the axial displacement of the cutting sleeve or the biopsy needle holder. In order to detect these modifications, photocells or

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microswitches inside the housing, especially the extension of the base block 8. In the cutting sleeve in case of measurement of the modification in relation to a photocell a positioning nail 103 is additionally placed, while in the case of the threaded spindle of the vacuum / pressure generating device the free end 61 protruding from the plunger unit can be consulted as a measuring point. Whenever the anterior biopsy needle holder is used as a measuring point with a photocell, no additional positioning nail is needed. The embedded photocells are covered due to possible contamination with suitable, transparent material. The positioning nail 103 imposes a groove in the biopsy needle holder. In corresponding points, in the extension 46 of the base block 8, recesses 107 are provided, in which photocells or microswitches are mounted, which either interact with the free end 61 of the plunger spindle, with the positioning nail or the needle holder from the edge of biopsies 120 (Figure 15). These signals (actual value) are processed in the electronic equipment and form the control signals.

The other system is based on the measurement of the number of revolutions of the direct current geared motors, which became units of length, which is especially convenient then when the modifications are made by means of the geared motors. According to this, a generator that interacts with a photocell placed in the DC motor housing is placed on the DC motor shaft. This generator is constituted (see Figure 3) by a two-arm helical wheel 131 and a photocell connected to the motor. These generators in the two drive motors supply the account units for the photocells, which are forwarded to the programmable microprocessor, which adjusts this recorded data with the specifications stored above and due to this the control pulse is activated. Since DC motors operate in a load dependent manner with a speed of approximately 10,000 -12,000 R / min. and on the other hand the planetary gear connected subsequently, arranged on the output side, which interacts with the spindle drive, considerably reduces the number of revolutions, a precise longitudinal control is thus possible. The longitudinal displacement by means of the spindle drive is proportional to the number of output revolutions an always equal magnitude and the number of revolutions is therefore sufficient as a control signal for the precision of the longitudinal displacement. To precisely determine the position of the cutting sleeve 3 as well as the piston 54 at the start, that is, after the introduction of the element that can be removed and the closing of the housing cover 10, the DC motor 58 rotates the piston 54 as far as the stop in the injection base and the DC motor 21 drives the cutting sleeve drive to the zero position, bringing the sprocket 74 in the threaded spindle nut 75 towards the stop (the threaded spindle nut 75 passes over the cogwheel 74). From this zero position the control of the individual stages is then carried out through the comparison of specifications and real value. The necessary cables from the transducer to the electronic equipment are housed in the housing, in the same way the printed circuit board with the electronic components (space 39). It is also possible if necessary the combination of the two control systems described.

List of reference numbers

1 Handpiece 2 Biopsy needle 3 Cutting sleeve 4 Connecting element 5 Vacuum / pressure generating device 6 Housing end cover (left) 7 Housing end cover (right) 8 Base block 9 Bottom of the housing 10 Housing cover 11 Locking latch 12 Trailing stop 13 Step 14 Hole 15 Step 16 Step 17 Pin 18 Microswitch 19 Drive bolt 20 Item that can be removed 21 DC motor 22 Wall 23 Toothed roller 24 Shaped space of U 25 Wall 26 Block 27 Slot

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28

Tension car

29

Tapped hole

30

Cap screw

31

Spiral spring

5

32 End piece

33

Double lever

3. 4

Pressure spring

35

Axis

36

Support

37

Biopsy needle holder

38

Holes

39

Side

40

Tongue

41

Tension carriage surface

fifteen

42 Surface extension

43

Sliding surface

44

Block surface 26

Four. Five

Recess

46

Cover

47

Plastic piece

48

Threaded spindle nut

49

Support element

fifty

Multiple edge

51

Injection fund

25

52 Injection body

53

Threaded spindle

54

Plunger

55

Cogwheel (crown gear)

56

Drive pinion

57

Control Panel

58

DC motor gearmotor

59

Cross plate

60

Surface

61

Free end

35

62 Introduction Element

63

Connecting tube

64

Outlet connection tube

65

Recess

66

Chamfer

67

Vent hole

68

Blade (longitudinal edges)

69

Piston / cylinder unit

70

Needle tip

71

Sample extraction space

Four. Five

72 Knife

73

Threaded spindle sleeve

74

Cogwheel

75

Threaded spindle nut

76

Shutter element

77

Recesses

78

Plastic disc

79

Plug

80

Knurled disc

81

Guide roller

55

82 Recess

83

Metallic piece

84

Safety wing

85

Front surface

86

87

Central rib

88

Drive key

89

Programming key

90

Tensioning key

91

Resume diode

65

92 Sample extraction diode

93

Ejection diode

10-20-2011

94 Tensioning diode 95 blocking diode 96 Battery Charging Diode 97 Step

5 98 Step 99 Dual arm lever arm 100 Lever part 101 Left guide roller flanks 102 Right guide roller flanks

10 103 Positioning clamp 104 Axis 105 Drive device (empty) 106 Drive device (biopsy needle, tensioning device) 107 Cut-outs

15 108 Tabs 109 Auxiliary insertion medium 110 Pin 111 Accumulator 112 Plastic part

20 113 Surface 114 Separator plate 115 Guide hole 116 Stringer 117 Clamping parts

25 118 N.N 119 Notch 120 N.N. 121 Washer 122 Lip

30 123 Highlight 124 Short spiral spring 125 Washer 126 Tubular part 127 Highlight

35 128 Distal hole in carriage 129 Hole in proximal side in block 26 130 Photocell 131 Helical wheel 0 Deformed position

40 S Wrench width A Internal distance X Proximal displacement X Distal displacement right turn angle Left turn angle H Height of sample extraction space

45 F Opening height T Partial part r External diameter r Internal diameter

55 E03711931

10-20-2011

Claims (51)

1. Biopsy device for tissue extraction as a handpiece with at least one tensioning and launching device that can be requested with elastic force in the form of a tensioning carriage (28) for a biopsy needle unit, which has an outer hollow needle (3) with a distally sharp cutting blade as well as a hollow biopsy needle (2) placed inside the outer hollow needle (3) with a tissue sample extraction space (71) provided therein distal end zone, which is placed in a biopsy needle holder (37), which can be brought into operational contact with at least the tension carriage (28), in which the distal needle areas of the hollow needle (3) outer and biopsy needle (2) hollow for tissue removal protrude from the carcass, and, in which the handpiece features a carcass with a carcass cover (10), in which in case of open position components can be firmly integrated into the inside of the housing, characterized because a pressure source (5) is provided that can be attached with the hollow biopsy needle (2), and because inside the housing

-

at least a first and second drive unit (21, 58) are integrated, in which - by taking the tension carriage (28) it can be brought into operational contact with the first drive unit (21) so that the tension carriage ( 28) it can be transferred to a tensioned state and it can be locked in it, and it can be brought a drive means (74) placed in the outer hollow needle to operative contact with the first drive unit (21), by which the needle can move outer hollow (3) rotating around the longitudinal direction of the needle, so that the outer hollow needle (3) is displaced with respect to the longitudinal axis of the hollow biopsy needle (2), and -the source of pressure (5), which is tightly connected to gases in the proximal area of the biopsy needle (2) hollow with it through at least one connecting duct (4) and which can be brought into operational contact with the second drive unit (58) to generate a pressure level, the joint conduit (4) running at least partially inside the housing.

2.

Biopsy device according to claim 1, characterized in that the biopsy needle unit is integrated so that it can be released and secured in the biopsy needle holder (37), wherein the inner biopsy needle (2) is proximally attached with a connection piece (47), through which the gas-tight connection duct (4) can be connected with the inner biopsy needle (2) and which has a fixing contour (49) that can be inserted in a counter-contour provided within the biopsy needle holder (37), so that the inner biopsy needle (2) is fixed at least in the longitudinal direction of the needle in the biopsy needle holder, and the hollow needle (3 ) External provides at least one partial section longitudinally to its outer perimeter a threaded contour (73), which is engaged with a threaded counter-contour attached at least so that it can be released and firm with the biopsy needle holder (37) , so that the outer hollow needle (3) can move in the longitudinal direction of the needle with respect to the inner biopsy needle (2).

3.

Biopsy device according to claim 2, characterized in that the connection piece (47) provides a retaining element (50) that is in contact with operative surfaces of the biopsy needle holder (37), such that the biopsy needle ( 2) Inner can be held fixedly in its longitudinal direction of the needle in positions that can be predetermined.

Four.

Biopsy device according to claim 2, characterized in that a means that increases friction between the two needles is provided between the outer hollow needle (3) and the hollow biopsy needle (2).

5.

Biopsy device according to claim 4, characterized in that the connection piece (47) provides a retention element (50) that is in contact with operative surfaces of the biopsy needle holder (37), such that the biopsy needle ( 2) inside can be retained in its longitudinal direction of the needle in positions that can be predetermined, such that a gap is present between the operative surfaces and the retaining element, whereby a limited angle rotation of the biopsy needle is possible (2) hollow around its longitudinal axis in both directions of rotation.

6.

Biopsy device according to claim 1 or 5, characterized in that by means of the bilateral rotation of the outer hollow needle (3), actuated by means of the drive (74) that is engaged with the first drive unit (21), the needle hollow biopsies (2) rotate together in the path of the high friction prevailing between the two needles (2, 3), the rotation movement of the hollow biopsy needle (2) being limited in both directions of rotation by the retention element ( 50) associated with the strike.

7.

Biopsy device according to claim 1, characterized in that an elastic sealing element (76) that seals both needles (2, 3) is sealed tightly in the hollow needle (3) and the hollow biopsy needle (2). gases with respect to each other.

8.

Biopsy device according to claim 2, characterized in that the biopsy needle holder (37) has a coupling structure (77), which can be inserted into a coupling counter-structure (40) provided in the tension carriage (28).

55 E03711931 10-20-2011

9.

Biopsy device according to claim 1, characterized in that the pressure source (5) has a piston cylindrical unit (69) whereby a pressure level prevailing as partial vacuum or depending on the movement of the piston within the cylindrical unit can be generated overpressure

10.

Biopsy device according to claim 9, characterized in that the cylindrical unit (52) is configured as an injection body and has a cylindrical base (51) with a connecting tube (63) for a gas-tight connection to the junction conduit (4) as well as a cylindrical opening opposite the cylindrical base (51), because the piston unit provides a threaded spindle (53), at one of whose ends the plunger is placed

(54) and whose other end is entered by a threaded spindle nut (48) provided in the cylindrical opening of the cylindrical unit (52), which has a circumferential contour (55) configured as a cogwheel, which can be engaged with the second drive unit, and because in case of rotation of the threaded spindle nut (48) the threaded spindle (53) can be axially displaced together with the plunger (54) with respect to the cylindrical unit (52).

eleven.

Biopsy device according to claim 9 or 10, characterized in that the cylindrical unit (52) in the area of the cylindrical opening within the cylindrical wall provides at least one ventilation opening (67), so that in a proximal piston position to the cylindrical opening the air can be evacuated from the cylindrical space included between the plunger (54) and the cylindrical base (51).

12.

Biopsy device according to claim 9, characterized in that the cylindrical piston unit (69) has a cylindrical longitudinal axis, because the cylindrical piston unit (69) is arranged next to the biopsy needle unit inside the housing of so that the longitudinal axis of the needle of the biopsy needle unit and the cylindrical axis of the cylindrical piston unit (69) run in a parallel manner, and because the joint conduit (4) has a conduit path in the form of OR.

13.

Biopsy device according to one of claims 1 to 12, characterized in that the joint duct (4) is a largely optically transparent flexible tube duct that allows relative movement between the pressure source (5) and the biopsy needle (2) hollow.

14.

Biopsy device according to one of claims 1 to 13, characterized in that the biopsy needle unit integrated in a biopsy needle holder (37) and the pressure source (5) gas-tightly connected through the gas duct union (4) with the biopsy needle (2) hollow are configured as a module

(29) unit that can be inserted into the housing as well as that can be removed again from the housing.

fifteen.

Biopsy device according to claim 14, characterized in that the module (29) constituted by the biopsy needle holder (37), in which the biopsy needle unit, the joint duct (4) and the source are integrated of pressure (5) can be inserted so that it can be released and firm in an arrangement that can be predetermined in a spatially fixed manner in an auxiliary means of introduction (109), by means of which the module (29) can be implemented inside the Case.

16.

Biopsy device according to claim 1, characterized in that the tension carriage (28) by means of the drive means (74), which is in contact with a secondary axis of the first drive unit (21), as well as the threaded contour (73 ) which can move in rotation due to it and the axial displacement of the outer hollow needle (3) that can be caused due to it can be transferred to the tensioned state, the actuating means (74) resting on one side against a support (36) which serves as a mechanical counter-support, which is fixedly provided to the housing, and because upon reaching the tensioned state the tension carriage (28) can be locked mechanically.

17.

Biopsy device according to claim 1 or 16, characterized in that the tension carriage (28) locked in the tensioned state can be unlocked by means of an unlocking mechanism, so that the tension carriage (28) and attached with it the biopsy needle holder (37) can be suddenly transferred to the relaxed state, the biopsy needle unit distally moving, ie the outer hollow needle (3) and the biopsy needle (2) hollow together.

18.

Biopsy device according to claim 1 or 16, characterized in that the first drive unit (21) provides as a secondary axis a toothed roller (23), in which the drive means engages

(74) configured as a cogwheel.

19.

Biopsy device according to claim 1, characterized in that the first and second drive unit (21, 58) is configured as an electric direct current motor with planetary gear connected subsequently.

twenty.

Biopsy device according to claim 10 or 19, characterized in that the second drive unit (58) provides a secondary shaft with a drive pinion (56) that can be engaged with the circumferential contour (55) configured as a cogwheel of the threaded spindle nut (48) of the cylindrical piston unit (69).

twenty-one.

Biopsy device according to claim 1, characterized in that a base block (8) is provided

55 E03711931 10-20-2011 joined so that it can be released and firm with the inside of the housing, which provides recesses for fixing the first and second drive unit (21, 58) so that their secondary axes run separately from each other and in parallel one with respect to the other, because in the base block (8) there is provided a stop element (26) from which a guide bolt (30) starts, along which the tension carriage (28) can be moved with force request elastic, and because the base block (8) provides recesses for the introduction of the biopsy needle unit embedded in the biopsy needle holder (37) as well as allowing a placement of the pressure source (5).

22

Biopsy device according to claim 21, characterized in that the tension carriage (28) is applied with elastic force on both sides along the guide bolt (30), so that the tension carriage (28) in the relaxed state can be deflected from a resting position on both sides along the guide bolt (30).

2. 3.

Biopsy device according to claim 1, characterized in that an energy supply unit (11) in the form of a battery or a rechargeable accumulator is provided inside the housing.

24.

Biopsy device according to claim 23, characterized in that the power supply unit is separated by a separator plate (114) from the area of the tension carriage (28) as well as from the pressure source (5).

25.

Biopsy device according to claim 1, characterized in that a control unit for controlling the first and second drive unit (21, 58) is provided in the housing, and because the control unit as well as a release of the tensioner carriage lock ( 28) can be operated by a control panel (57) placed on an outer wall of the housing.

26.

Biopsy device according to claim 25, characterized in that the control unit for controlling the drive units configured as electric direct current motors respectively comprises a speed measurement unit.

27.

Biopsy device according to claim 26, characterized in that the unit for measuring the number of revolutions is respectively carried out optically by means of a photocell and a transmitter seated directly on the motor shaft.

28.

Biopsy device according to claim 25, characterized in that the control unit provides at least one programmable microprocessor.

29.

Biopsy device according to claim 25, characterized in that the control panel comprises at least the following control keys (88, 89, 90), whose control possibility as well as the control function can be marked respectively by different light signals (91, 92 , 93, 94, 95): a "biopsy key" (89) occupied with three functions, whose different functions can be marked respectively by different light signals (91, 92, 93) and comprises the following functions:

-renewal function (91), that is to say transfer all the components integrated in the housing to a desired position, -function of tissue extraction (92), that is to say generate a partial vacuum inside the hollow biopsy needle by means of the pressure source, open the tissue sample extraction space (71) by pushing back the outer hollow needle (3) with respect to the hollow biopsy needle (2), cutting process by means of axial periodic forward and backward movements of the hollow biopsy needle (2) as well as tissue separation process by advancing the outer hollow needle (3) through the tissue sample extraction space (71) with respect to the hollow biopsy needle (2), aerate the pressure source (5) to undo a partial vacuum, - tissue ejection function (93), that is to say partially opening the tissue sample extraction space (71) by not completely removing the outer hollow needle (3), generating a sob repression within the pressure source, whereby tissue material separated from the tissue sample extraction space (71) is released as well as pushing the outer hollow needle (3) back completely and thereby completely opening the space of extraction of tissue samples (71), - "tension key" (90), by means of which the tension carriage (28) can be transferred to the tensioned state and - "launch key" (88), by means of which actuation is triggered distally the tension carriage (28) together with the biopsy needle unit at a certain distance.

30

Biopsy device according to claim 22 or 29, characterized in that the control unit for performing the tissue extraction function during the cutting process displaces the first drive unit in periodic sequence cuts in respectively opposite turning movements, so that the outer hollow needle (3) and the biopsy needle (2) hollow make forward and backward movements along its longitudinal needle axis.

31.

Biopsy device according to claim 29, characterized in that the control unit provides for a safety delay, whereby at least the tension key function (90) as well as the function of

55 E03711931 10-20-2011 tissue ejection in case of command, compared to the command behavior of the rest of the control keys.

32

Biopsy device according to claim 1, characterized in that the housing is in the form of a parallelepiped, with a folding housing cover (10) coupled by means of articulation in the housing as well as a first and second front side (6, 7), presenting the first front side (6) at least one opening through which the distal needle areas of the outer hollow needle (3) and the hollow biopsy needle (2) protrude out of the housing, and the second front side (7) provides at least two recesses (15, 16) through which at least the connecting duct (4) is conducted.

33.

Biopsy device according to claim 32, characterized in that a microswitch (19) is provided in the recess (16) of the second front side (19) which can be operated by means of the pressure source (5) in the case of the closed housing, so that an energy supply for the drive unit (21, 58) can be unlocked.

3. 4.

Biopsy needle module for implementation in a biopsy device according to one of claims 1 to 33, which has the following components:

-a biopsy needle unit integrated in a biopsy needle holder (37) comprising an outer hollow needle (3) with a distally sharp cutting blade as well as a hollow biopsy needle (2) placed inside the needle hollow (3) with a tissue sample extraction space (71) provided in its distal end area, in which the outer hollow needle slides with respect to the inner hollow needle (2), -a junction duct (4) as well as - a source of pressure (5), in which the junction duct (4) gasically connects the biopsy needle (2) hollow with the source of pressure (5).

35

Biopsy needle module according to claim 34, characterized in that the biopsy needle unit is integrated so that it can be released and secured in a biopsy needle holder (37), the inner biopsy needle (2) being joined proximally with a connection piece (47), through which the gas-tight connection conduit (4) can be connected with the inner biopsy needle (2) and which has a fixing contour (49) that can be inserted into a counter-contour provided within the biopsy needle holder (37), such that the inner biopsy needle (2) is fixed at least in the longitudinal direction of the needle in the biopsy needle holder, and the hollow needle (3) The outside provides at least a partial section along its outer perimeter a threaded contour (73) that is engaged with a threaded counter-contour (75) attached at least so that it can be released and secured with the biopsy needle holder (37 ), of mane ra that the outer hollow needle (3) can move relative to the inner biopsy needle (2) in the longitudinal direction of the needle.

36.

Biopsy needle module according to claim 34, characterized in that an actuating means (74) is placed on the outer perimeter of the outer hollow needle (3), by means of which the outer hollow needle (3) can be rotated about the longitudinal direction of the needle, so that the outer hollow needle (3) can move axially with respect to the biopsy needle holder (37) and consequently to the hollow biopsy needle (2).

37.

Biopsy needle module according to claim 34, characterized in that the connection piece (47) provides a retaining element (50) that is in contact with operative surfaces of the biopsy needle holder (37), such that the needle Inner biopsies (2) can be held fixedly in their longitudinal direction of the needle in positions that can be predetermined.

38.

Biopsy needle module according to claim 34, characterized in that a means that increases friction between the two needles is provided between the hollow needle (3) and the hollow biopsy needle (2), which is configured as an element shutter (76).

39.

Biopsy needle module according to claim 38, characterized in that the connection piece (47) provides a retaining element (50) that is in contact with operative surfaces of the biopsy needle holder (37), such that the needle Inner biopsies (2) can be retained in their longitudinal direction of the needle in positions that can be predetermined, such that a gap is present between the operative surfaces and the retaining element, whereby a limited angle rotation of the needle is possible of biopsies (2) hollow around its longitudinal axis in both directions of rotation.

40

Biopsy needle module according to claim 34, characterized in that the biopsy needle holder

(37)

it has a coupling structure (77) that can be inserted into a coupling counter structure

(40)

provided in a tension car (28).

41. Biopsy needle module according to claim 34, characterized in that the pressure source (5) has a cylindrical piston unit (69), by which a pressure level can be generated depending on the movement of the plunger within the cylindrical unit prevailing as partial vacuum or overpressure. 50 E03711931 10-20-2011 42. Biopsy needle module according to claim 41, characterized in that the cylindrical unit (52) is configured as an injection body and has a cylindrical base (51) with a connecting tube (63) for a gas tight connection to the connecting duct (4) as well as a cylindrical opening opposite the cylindrical base (51), because the piston unit provides a threaded spindle (53), at one of whose ends the plunger is placed

(54)

and whose other end is entered by a threaded spindle nut (48) provided in the cylindrical opening of the cylindrical unit (52), which has a circumferential contour (55) configured as a cogwheel, which can be engaged with a unit drive, and because in case of rotation of the threaded spindle nut

(48)

The threaded spindle (53) can be moved axially together with the plunger (54) with respect to the cylindrical unit (52).

43

Biopsy needle module according to claim 42, characterized in that the cylindrical unit (52) in the area of the cylindrical opening within the cylindrical wall provides at least one ventilation opening (67), so that in a proximal piston position to the cylindrical opening the air can be evacuated from the cylindrical space included between the plunger (54) and the cylindrical base (51).

44.

Biopsy needle module according to claim 41, characterized in that the cylindrical piston unit

(69) has a cylindrical longitudinal axis, because the cylindrical piston unit (69) is arranged next to the biopsy needle unit, such that the longitudinal axis of the needle of the biopsy needle unit and the cylindrical longitudinal axis they run in a parallel manner, and because the connecting duct (4) has a U-shaped duct path.

Four. Five.

Biopsy needle module according to claim 34, characterized in that the joint conduit (4) is a largely optically transparent flexible tube conduit that allows relative movement between the pressure source (5) and the biopsy needle (2 ) hollow.

46.

Biopsy needle module according to claim 34, characterized in that the biopsy needle module composed of the biopsy needle holder (37), in which the biopsy needle unit, the junction conduit (4) is thus integrated as the pressure source (5) can be inserted so that it can be released and firm in an arrangement that can be predetermined in a spatially fixed manner in an auxiliary means of introduction (109).

47

Biopsy needle module according to claim 34 or 35, characterized in that the tissue sample extraction space (71) is axially delimited by two longitudinal side edges that are configured as cutting edges (68).

48.

Biopsy needle module according to claim 47, characterized in that the hollow biopsy needle (2) is configured at least in the area of the tissue sample extraction space (71) as a straight hollow cylinder that provides for a local recess axial, whose depth of radial recess amounts to less than half the internal diameter of the hollow cylinder and whose longitudinal lateral edges that delimit both sides axially to the recess are configured as cutting edges, so that in the area of the lateral edges The internal radius described by the hollow cylinder is continuously adjusted to the external radius.

49.

Biopsy needle module according to claim 34, characterized in that the hollow biopsy needle (2) at the proximal end of the tissue sample extraction space (71) provides a narrowing that reduces the cross-section of the hollow channel included by the needle of biopsies, which leaves a hollow channel passage opening open in the tissue sample extraction space (71) in the lower area of the tissue sample extraction space (71).

fifty.

Biopsy needle module according to claim 49, characterized in that the narrowing covers approximately 60-70% of the cross section of the hollow channel, and the narrowing is configured as a stopper protruding into the hollow channel or as an element of surface protruding on the cross-sectional surface of the hollow channel.

51.

Biopsy needle module according to claim 35, characterized in that distally to the biopsy needle holder (37) a guide roller (81) that slides on the outer perimeter of the outer hollow needle (3) is provided, which has a passage opening sized to a large extent exactly to the outer perimeter of the outer hollow needle (3), through which the outer hollow needle (3) passes and which can be inserted in a passage (13) in the cover of end of the housing (6) distal.

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