Abstract:
A biopsy device includes a drive unit configured to receive a disposable unit having a needle carrier. The drive unit is configured to move a cutting element such that the needle carrier is driven a predetermined distance to move a needle-shooting mechanism to a cocked configuration. A user-actuatable control is configured to release the needle-shooting mechanism to cause the needle-shooting mechanism to shoot a biopsy needle simultaneously with the cutting element by an amount of the predetermined distance.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This is a division of application Ser. No. 14/580,483 filed Dec. 23, 2014, now U.S. Pat. No. 9,439,631, which is a continuation of application Ser. No. 13/449,996 filed Apr. 18, 2012, now U.S. Pat. No. 8,951,209, which is a division of prior application Ser. No. 11/680,882 filed Mar. 1, 2007, now U.S. Pat. No. 8,172,773, which is a continuation of prior application Ser. No. 10/500,518, filed Mar. 1, 2005, now U.S. Pat. No. 8,002,713, which claims priority as a  371  application of PCT/EP2003/02285, filed Mar. 5, 2003, which claims priority to DE 10212154.0, filed Mar. 19, 2002, DE 10235480.4, filed Aug. 2, 2002, and DE 10248425.2, filed Oct. 17, 2002, the entireties of which are hereby incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention relates to a biopsy device for tissue removal in the form of a manual component with at least one elastic force-actuated clamping cradle for a biopsy needle unit, which features an outer hollow needle with a distally sharpened cutting blade and a hollow biopsy needle mounted in the interior of the hollow needle with a tissue sample removal chamber provided in its distal end region, wherein the outer hollow needle is slidably seated relative to the hollow biopsy needle, as well as with a pressure source connectable to the hollow biopsy needle. A biopsy needle module suitable for operation of the biopsy device is also described. 
       BACKGROUND OF THE INVENTION 
       [0003]    German Patent No. DE 40 41 614 C1 discloses a suction biopsy device, which is designed as a manual device and possesses a vacuum source and a biopsy cannula connector, which can be rotated by means of a rotation drive connected via a flexible shaft. A biopsy cannula designed as a hollow cannula can be connected to the biopsy cannula connector, and said biopsy cannula preferably features a circumferential, sharpened cutting edge at its distal end, along the hollow channel of which a vacuum can be applied by means of the vacuum source, which is designed as a piston-cylinder unit, as soon as the hollow cannula has been positioned at a specific intracorporeal tissue location. 
         [0004]    International Publication No. WO 96/28097 discloses a similar vacuum-supported biopsy device which, although it does not provide for a rotatable hollow cannula, does feature a syringe piston arrangement for generating a vacuum and disposed inside a manual device. 
         [0005]    German Publication No. DE 100 34 297 A1 describes, in contrast to the preceding suction biopsy devices with only one hollow needle, a tissue removal endoscopy instrument possessing a biopsy needle arrangement, which features a circumferentially sharpened hollow needle at its distal end and a hollow biopsy needle disposed inside the hollow needle, wherein the internally disposed biopsy needle features at its distal end a depression for removal of tissue samples. A suction instrument for generating a vacuum is disposed on the proximal end of the hollow biopsy needle. Tissue is removed by pushing the biopsy needle arrangement in a shared position into a tissue region to be examined, wherein the biopsy needle features a distal tip, which slightly protrudes from the hollow needle at its distal end, so as to facilitate penetration of the biopsy needle arrangement into the tissue, on the one hand, and to prevent penetration of tissue into the interior of the hollow needle, on the other. 
         [0006]    When the biopsy needle arrangement is suitably positioned inside the tissue, the hollow needle is pulled a predetermined distance in a proximal direction, wherein the internally disposed biopsy cannula remains in its position and the depression is exposed. The vacuum applied along the biopsy needle results in an active lowering and/or pulling in of surrounding tissue fragments into the depression. When the distal end of the hollow needle with its sharpened distal end is pushed forward over the biopsy needle in controlled manner, a tissue fragment is severed and enclosed within the depression in the biopsy needle. When the entire biopsy needle arrangement is pulled back, the severed tissue sample is removed from the body for examination purposes. The entire tissue removal process described above is performed in such a way that the needle movements and the vacuum application can be performed manually, individually and separate from one another. 
         [0007]    In contrast, the biopsy needle arrangement described in International Publication No. WO 98/25522 permits a relative motion, actuated by elastic force, between the internally disposed hollow biopsy needle and the outer hollow needle enclosing the biopsy needle. In this case, the biopsy needle is also positioned at the distal end of the sharpened distal tip of the hollow needle, wherein a vacuum source is provided to supply a targeted vacuum through the hollow biopsy needle and into the region of its depression and supports the tissue intake process. The process of positioning the biopsy needle relative to and, ultimately, inside the tissue region to be examined is exclusively manual. This type of positioning, especially when examining hard tissue regions, produces only unsatisfactory biopsy results. 
         [0008]    Similar vacuum-supported tissue removal devices are, moreover, disclosed by British Patent Publication No. GB 2 018 601 A and European Patent Publication No. EP 0 890 339 A1. In these cases, however, the vacuum sources, as well as other control units needed to guide the biopsy needle in a controlled manner, are designed and featured as external auxiliary units to be connected to the biopsy needle arrangement. US Publication No 2001/0011156 A1 also describes a vacuum-supported biopsy device comprising a compactly designed hand-held device, the housing of which contains all drive elements necessary for the needle drive of the biopsy needle arrangement. However, a vacuum source separate from the hand-held device is provided which is connectable by means of a corresponding supply line to the needle arrangement inside the hand-held device at a suitable connection point. 
       SUMMARY OF THE INVENTION 
       [0009]    Commencing with a biopsy needle arrangement according to International Publication No. WO 98/25522, which is viewed as the most relevant state of the art, the underlying objective of the invention is to further develop a biopsy device for tissue removal, which is designed in the form of a hand-held device and features at least one elastic force-actuated clamping and shooting device in the form of a clamping cradle for a biopsy needle unit which features an outer hollow needle with a distally sharpened cutting blade as well as a hollow biopsy needle seated inside the hollow needle with a tissue sample removal chamber at its distal end region, wherein the outer hollow needle is slidably seated relative to the hollow biopsy needle, and which features a vacuum source connectable with the hollow biopsy needle, in such a way that ease of operation of the biopsy device is optimized to such an extent that improved examination of tumors can be guaranteed, in that the size and structure of the tissue sample removable with the biopsy device is such that it provides a pathologist with an excellent basis for further histological examination. In addition, an objective of the invention is to improve the tissue removal process itself. Specifically, this means that the needle movements of the biopsy needle unit required for the tissue severing process and the generation of pressure for targeted development of a vacuum must be precisely matched to one another. An essentially manual matching of needle movements to vacuum generation, as in the case of International Publication No. WO 98/25522, is to be avoided. 
         [0010]    In the interest of improving ease of operation, the biopsy device should also feature as a compact a design as possible and, as a hand-held device, should allow for easily moveable single-hand operation, if necessary, so that a single operator can perform the tissue removal process with one hand. In the same vein, the biopsy device should be designed as an autonomously operating hand-held instrument, the operation of which does not require any external control or supply units that would require connecting lines connected to the hand-held device. This applies, in particular, to the avoidance of a connecting line to an external vacuum source and/or power supply. Moreover, the pressure source with which the generation of a vacuum is preferably to be achieved should be designed to be as simple as possible and should operate reliably. If possible, the removal of tissue samples should occur in such a way that the user, in most cases a pathologist, can be provided with a non-drilled and undamaged tissue sample for evaluation. Finally, the biopsy device should be inexpensive and should allow for a cost-efficient solution with respect to replaceable biopsy needles, which are to be viewed as disposable material. 
         [0011]    The solution of the objective underlying the invention is a biopsy device designed in accordance with the present invention, which may comprise a biopsy needle module that can be implemented in the inventive biopsy device for its functional application. In addition, a method of removing tissue using the inventive biopsy device is disclosed. Advantageous embodiments of the inventive concept can be derived from the description, especially with reference to the exemplary embodiments. 
         [0012]    The inventive biopsy device for tissue removal in the form of a manual component with at least one elastic force-actuated clamping and shooting device in the form of a clamping cradle for a biopsy needle unit, which features an outer hollow needle with a distally sharpened cutting blade and a hollow biopsy needle mounted in the interior of the hollow needle with a tissue sample removal chamber provided in its distal end region, wherein the outer hollow needle is slidably seated relative to the hollow biopsy needle, as well as with a pressure source connectable to the hollow biopsy needle, is characterized, according to the invention, by the fact that the hand-held unit  1  features a housing in which at least two drive elements as well as the clamping and shooting device in the form of a clamping cradle are securely and detachably integrated. The two drive elements and the clamping cradle are designed and disposed inside the housing in such a way that the biopsy needle unit seated in a biopsy needle carrier and a pressure source connected to the biopsy needle unit can be implemented in the interior of the housing, and can actively engage the components disposed therein and mentioned above in a suitable manner. The biopsy needle unit, with its hollow biopsy needle, is connected in a gas-tight manner to the pressure source via a connecting line and represents a self-contained biopsy needle module which, for reasons of sterility, must be viewed as a disposable article. 
         [0013]    On the one hand, the biopsy needle carrier serves as a mechanical receptacle structure for the biopsy needles, of which at least the outer hollow needle, which will be described in detail below, is moveable, by means of a spindle mechanism, by rotation around the longitudinal axis of the needle and along the hollow biopsy needle. On the other hand, the biopsy needles are jointly detachably connected to the clamping cradle through the biopsy needle carrier, through which the process of shooting both biopsy needles into a tissue region to be examined is performed. To this end, the biopsy needle carrier features a suitable coupling structure, which can be inserted into a corresponding counter-coupling structure on the clamping cradle. 
         [0014]    In a preferred embodiment, the biopsy needle carrier features a housing module, open at one end, through the open end of which the biopsy needles can be securely but detachably integrated into the biopsy needle carrier. In addition, the design of the biopsy needle carrier, with its open end being open, permits a drive element attached to the outer circumference of the outer hollow needle to mechanically engage a gear component, which is attached to the drive shaft of one of the drive units. As a result of this kinematic active connection existing between the outer hollow needle and the drive unit, the outer hollow needle can brought into rotation, which results in said outer hollow needle being shifted relative to the needle longitudinal axis of the hollow biopsy needle, which is firmly attached in the needle longitudinal direction of the biopsy needle carrier. It is precisely this kinematic mode of action that also triggers the clamping of the clamping cradle, in that, once a mechanical limit stop is reached on the outer hollow needle, which is longitudinally moveable relative to the hollow biopsy needle, the biopsy needle carrier and the biopsy needle arrangement are shifted in the clamping direction, together with the clamping cradle, until the clamped position is attained. 
         [0015]    As a result, two functions can be served using only one driving mechanism, i.e., clamping the clamping cradle and triggering the motion of the biopsy needles, which is not limited to the relative longitudinal displacement of both biopsy needles, but rather, as will be demonstrated below, optionally includes additional rotational movements around the needle&#39;s longitudinal axis. In addition to the drive unit mentioned above, the sole function of the second drive unit is the targeted generation of a pressure level within the hollow biopsy needle and the tissue sample removal chamber connected to it. Depending on the respective procedure being performed with the biopsy device, the pressure level represents either an overpressure or a vacuum, which can be generated and adjusted in a targeted manner using the pressure source. 
         [0016]    Using the biopsy device designed in accordance with the invention, it is possible to perform a fully autonomous tissue sample removal process which, moreover, can be performed by a physician in connection with single-handed operation. All procedures needed to remove a tissue sample take place automatically, i.e., without additional manual support, and can each be triggered by individual keystroke verifications on the biopsy device itself. 
         [0017]    The individual steps required for complete tissue removal are accomplished by the biopsy device in the following manner: 1) placement of the biopsy needle unit and the clamping cradle into a starting position (this first step is a form of reset function); 2) placement of the clamping cradle into a tensioned state; 3) triggering of a shot, by means of which the biopsy needle unit is distally shot into a tissue region to be examined; 4) automatic development of a vacuum, which can be applied by the pressure source, through the connecting line, along the hollow biopsy needle, and into the tissue removal chamber; 5) tissue severing process, in which the outer hollow needle is shifted proximally and, at the same time, the tissue removal chamber is released under vacuum conditions, which results in surrounding tissue material being sucked into the tissue removal chamber and being severed from the remaining tissue by the cutting action along the longitudinal edges laterally bordering the tissue removal chamber and configured as cutting edges, wherein the severing process is additionally supported by a periodic distally and proximally directed change in motion of the hollow biopsy cannula, so that, finally, the partially severed tissue sample, which has been sucked into the tissue sample removal chamber, is completely severed by the outer hollow needle being pushed distally forward; and 6) tissue sample removal process, which takes place outside the body, and in which the outer hollow needle proximally releases the tissue sample removal chamber, at least in part, and, due to application of overpressure through the hollow biopsy needle, especially in the lower region of the tissue sample removal chamber, severing of the tissue sample is brought about, as a result of which the tissue sample is easily removable from the tissue sample removal chamber. 
         [0018]    The procedures described above for careful tissue sample removal can be reliably and safely performed using the biopsy device of the invention. Of particular significance is the fact that the biopsy device is completely independent of external devices supporting the tissue removal process, while at the same providing a high degree of ease of operation, thus easily allowing for single-handed operation. The biopsy device will now be explained in detail while making reference to the exemplary embodiments described below. 
         [0019]    The biopsy device is especially advantageously characterized by the instrument panel to be operated by a treating physician, which is provided in an exterior side wall of the housing of the biopsy device and preferably features only three control keypads, which are installed in an especially clear manner and can be operated completely without error. Thus, for example, light signal fields are assigned to each control keypad, which provide the physician with information on the current operability of the individual control keypads and, furthermore, ensure a predetermined completion of functions in accordance with the process described above. Functions that are to be performed with special care, such as the clamping of the clamping cradle or the operation of the tissue sample removal process, are equipped with a time delay feature, so that they cannot be triggered inadvertently. The biopsy device is advantageously characterized by these and many other special features, as can be deduced from the following discussion, in which reference is made to the following exemplary embodiments. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0020]    In the following, the invention is described in exemplary fashion, but without limiting the general concept of the invention, on the basis of exemplary embodiments and while making reference to the drawings. 
           [0021]      FIG. 1  depicts a biopsy device with an opened housing lid (perspective view). 
           [0022]      FIG. 2  depicts a hand-held device with parts of the biopsy device arranged therein (without housing base and lid) and interchangeable biopsy unit (highlighted in a perspective view). 
           [0023]      FIG. 3  depicts a longitudinal section A-A through the biopsy needle shown in  FIG. 1 . 
           [0024]      FIG. 3 a    depicts a longitudinal section A-A through the biopsy needle shown in  FIG. 1  (as in  FIG. 3 ), proximal portion (enlarged). 
           [0025]      FIG. 3 b    depicts an enlargement of segment A in  FIG. 3   a.    
           [0026]      FIG. 3 c    depicts an enlargement of segment B in  FIG. 3   a.    
           [0027]      FIG. 4  depicts a cross-section B-B in  FIG. 3  (left section of housing). 
           [0028]      FIG. 5  depicts a cross-section C-C in  FIG. 3  (right section of housing). 
           [0029]      FIG. 6  depicts the right housing end lid (interior) with integrated micro switch. 
           [0030]      FIG. 7  depicts the front side of the control panel. 
           [0031]      FIG. 8 a    depicts the base block in the x-axis, viewed from the front (perspective view). 
           [0032]      FIG. 8 b    depicts the base block in the x-axis, viewed from behind (perspective view). 
           [0033]      FIG. 9 a    depicts the hand-held unit with the units of the biopsy device attached to the housing, without the housing lid and base and in the non-tensioned state. 
           [0034]      FIG. 9 b    depicts the locking mechanism of the clamping cradle, with the clamping cradle in the non-tensioned state. 
           [0035]      FIG. 10 a    depicts the depiction of  FIG. 9 a   , but with the clamping cradle in its tensioned position. 
           [0036]      FIG. 10 b    depicts the depiction of  FIG. 9 b   , but in the tensioned position and in the locked position. 
           [0037]      FIG. 11 a    depicts the biopsy needle tip in a side view. 
           [0038]      FIG. 11 b    depicts a longitudinal section through  FIG. 11 a    (sample removal chamber opened). 
           [0039]      FIG. 11 c    depicts the depiction of  FIG. 11 b   , but with (sample removal chamber half-opened). 
           [0040]      FIG. 11 d    depicts the depiction of  FIG. 11 b    (sample removal chamber closed by means of cutting sleeve. 
           [0041]      FIG. 11 e    depicts section A-A in  FIG. 11   a.    
           [0042]      FIG. 11 f    section B-B in  FIG. 11   a.    
           [0043]      FIG. 11 g    depicts an enlargement of the cut edge at A. 
           [0044]      FIG. 12  depicts the biopsy needle carrier with biopsy needle/cutting sleeve pressed and plastic component pressed in (from below, rotated by approximately 90°, perspective view). 
           [0045]      FIG. 12 a    depicts a section through the longitudinal axis of the proximal portion of the biopsy needle (enlarged). 
           [0046]      FIG. 12 b    depicts section B-B through the multiple edge of the biopsy carrier in the rotated state; left limit stop. 
           [0047]      FIG. 12 c    depicts section B-B as depicted in  FIG. 12 b   , but with multiple edge in its centered position. 
           [0048]      FIG. 12 d    depicts section B-B as depicted in  FIG. 12 b   , but pivoted; right limit stop. 
           [0049]      FIG. 12 e    depicts section A-A through needle deformation zone  0  of the biopsy needle and the cutting sleeve. 
           [0050]      FIG. 12 f    depicts the distal side of the biopsy needle with sample removal chamber and cutting sleeve in basic position, corresponding to the position of the multiple edge in  FIG. 12   c.    
           [0051]      FIG. 12 g    depicts the biopsy needle as depicted in  FIG. 12 f   , with pivoting of the sample removal chamber to the right and advanced cutting sleeve, corresponding to the position of the multiple edge as depicted in  FIG. 12   d.    
           [0052]      FIG. 12 h    depicts the biopsy needle as depicted in  FIG. 12 f   , with pivoting of the sample removal chamber and retracting cutting sleeve corresponding to the rotation of the multiple edge as depicted in  FIG. 12   b.    
           [0053]      FIG. 13  depicts the vacuum-pressure device, installation and drive (viewed from behind, perspective view). 
           [0054]      FIG. 14 a    depicts the vacuum-pressure device, with piston mounted on the syringe base (starting position for vacuum generation and end position for pressure generation, partial section). 
           [0055]      FIG. 14 b    depicts the vacuum-pressure device with retracted piston; end position of the vacuum stroke of the piston (partial section). 
           [0056]      FIG. 14 c    depicts the position of the piston following clearing of the ventilation hole; pressure balancing position (partial section). 
           [0057]      FIG. 14 d    depicts section A-A through the threaded spindle in  FIG. 14   c.    
           [0058]      FIG. 15  depicts the base block and biopsy needle/cutting sleeve, prepared for being loaded with photocells and microswitches for measurement of actual values. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0059]    The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected preferred embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention. 
         [0060]    In the exemplary embodiment depicted in  FIG. 1 , all components necessary for the completion of a vacuum biopsy are integrated into the interior space of the housing of a hand-held unit  1 , so that no cables or lines from the housing of the hand-held device to other external supply units are necessary. The hand-held unit  1  thus represents a complete vacuum biopsy device, which is freely moveable in all directions. 
         [0061]    The distal portion of the hollow biopsy needle  2  and the outer hollow needle  3 , which surrounds it coaxially and is referred to in the following as the cutting sleeve, protrude from the distal housing lid  6 . Said cutting sleeve is used to remove and/or completely sever the tissue sample. In most instances, a coaxial cannula, which is not depicted, is inserted into the tissue, into which this segment of the biopsy needle  2  with cutting sleeve  3  is introduced and is thus positioned in front of the tissue to be examined. A connecting element  4 , such as a transparent, flexible tube, which connects the pressure source disposed in parallel to the biopsy needle or the vacuum pressure-generating device  5  with the internal hollow space of the biopsy needle  2  in a gas-tight manner, is disposed outside the right proximal housing lid  7 . The hollow connecting element  4  lies in direct proximity to the housing lid  7 . 
         [0062]    The biopsy needle  2  with cutting sleeve  3  and additional elements, disposed in a biopsy needle carrier  37 , forms, together with the connecting element  4  and the vacuum pressure-generating device  5 , a biopsy needle module  20  that is easily removed in an upward direction and easily inserted, hereinafter referred to as the removable element, which can be replaced as needed ( FIG. 2 ). The housing lid  10  is opened for this purpose. As  FIG. 2 , in particular, shows, the biopsy device can be divided into parts that are firmly attached to the housing (disinfected parts) and a removable element  20  (sterile part). While the parts that are firmly attached to the housing are only disinfected, the removable element  20  is delivered in sterile packaging and is replaced as necessary, particularly with each new patient. As will be explained in detail later on, steps have been taken to ensure that the disinfected part is not contaminated with tissue fluid during use. 
         [0063]    In the exemplary embodiment described below, the vacuum pressure-generating device  5  is arranged in parallel to the biopsy needle unit. Within the scope of the invention, however, the vacuum pressure-generating device  5  can also be arranged in a prone position in the axle of the biopsy needle or the hand-held unit  1 . Furthermore, it does not require a separate connecting element if, for example, it is placed directly onto the end of the biopsy needle. In this case, the connecting element is to be viewed as a suitable flange connection, such as in the form of a Luer lock. 
         [0064]    A lower housing segment  9  and a housing lid  10  hinged in the housing end lids, together with a locking latch  11 , are positioned between the left and right housing end lids  6 ,  7 . The lower housing segment  9  is clamped between the housing end lids  6 ,  7  and/or connected to a base block  8  by means of tension rods or screws, some of which are screwed into the base block  8 . The housing lid  10  is hinged to an axle secured in the housing end lids  6 ,  7 . The housing lid  10  is closed prior to operation of the biopsy device, with the inside contour of the housing lid corresponding to the outside contour of the biopsy needle carrier  37 , which will be described in detail later on. The base block  8 , which is firmly connected to the lower housing segment by means, for example, of fixing elements and/or a screw connection, is disposed at approximately the center of the interior space of the housing. The drive elements for the vacuum pressure-generating device  5 , the cutting sleeve  3 , and the clamping device for the clamping cradle  28 , onto which the biopsy needle carrier  37  is mounted, are connected to the base block  8 . The base block  8  extends from the center of the housing to the left, and a plate joined to it cover the drives and serves as a support for the control board, which is arranged a protected manner inside or below the cover  46 . In addition, the base block  8  features a holder  36 , open at the top, for both the biopsy needle and cutting sleeve, as well as an additional insertion element  62  for the vacuum pressure-generating device  5 . 
         [0065]    To identify the position of the individual elements, as well as the position of the individual parts, especially in the interior space of the housing, a system of coordinates was drawn in  FIG. 1 , wherein the center point of the coordinates of the system lies at the center of the base block  8  ( FIG. 1 ). Accordingly, in the following description movement in the direction of the x-axis is considered left (distal) and movement away from the x-axis is considered right (proximal). For the remaining coordinates, movement in the direction of the y axis is considered upward, movement away from the y axis downward, movement in the direction of the z axis backward, and movement away from the z axis forward ( FIG. 1 ). Therefore, the system of coordinates divides the interior space of the housing and the remaining references into left and right, front and back, and top and bottom. To facilitate understanding, these rules were modified for depicting angled rotational movement of the biopsy needle, with rotation around the common longitudinal axis of the biopsy needle and the cutting sleeve being depicted as movement to the left (i.e., toward the front) and right (toward the back). 
         [0066]    With reference to these rules, the common drive mechanisms  106  for the clamping device and the cutting sleeve are located in approximately the lower, front, left portion of the interior space of the housing, and the drive mechanism for the vacuum pressure-generating device  5  in the upper, rear, left portion of the housing. The power supply for the drive motors and the remaining electronic components, such as the control and/or monitoring elements, are located in the lower, right portion; batteries or a storage battery  111 , such as a 7.2 V lithium ion battery, 1 Ah, are preferably used for this purpose. The front, right, upper interior space of the housing located above the battery space is used primarily for the clamping cradle  28  and locking element ( FIG. 5 ), which is connected to a block  26 , which is part of the base block  8 . The battery space is sealed at the top by a divider plate  114 . 
         [0067]    In the uppermost, front portion of the interior space of the housing, an insertable and removable biopsy needle carrier  37  is arranged in the U-shaped insertion holder  36 , open to the top, of the base block  8  and in the upward-pointing bracket  40  disposed on both sides of the clamping cradle  28 , a biopsy needle/cutting sleeve unit with drive components being rotatably supported in said biopsy needle carrier, which extends along virtually the entire length of the hand-held unit  1 . As described later on, the biopsy needle carrier is longitudinally displaceable by means of the clamping cradle. This means that in the non-tensioned state the left face of the biopsy needle carrier  37  almost rests against the housing end lid  6  and, in the tensioned state, the right face rests against the right housing end lid  7 . “Virtually the entire length” signifies that the biopsy needle carrier is shortened by at least the amount of interior housing space required for the clamping process. If the clamping path of the clamping cradle is, for example, 20 mm, the biopsy needle carrier must be displaceable by at least this amount. In general, the clamping path ranges from 15 to 25 mm, depending on the biopsy needle used. Consequently, it is advantageous to design the interior space to include the largest possible clamping path, plus a few mm. 
         [0068]    The clamping device (right, at front) itself comprises a clamping cradle  28  traveling on a pin  30 , the pin being screwed into the block  26  of the base block  8 . The pin  30  is proximally encircled by a spiral spring  31 . Another short spiral spring  124  is disposed on the pin  30  on the distal side of the clamping cradle. One side of this short spiral spring rests on the block  26 , while the other side rests on an inner lip  122  on the distal side of the clamping cradle. The spiral spring  31  rests on the opposite side (proximal side) of the lip of the clamping cradle. The locking mechanism (see, in particular,  FIGS. 9 b  and 10 b   ) of the clamping cradle is secured to the block  26 . The vacuum pressure-generating device  5  and parts of the drive are arranged in the upper, rear, right interior space of the housing; the drive motor for the reduction gear for the vacuum pressure-generating device  5  is located in the left, lower, rear region of the interior space of the housing. The housing lid, the lower housing segment, the housing end lid and the base block are preferably made of aluminum. 
         [0069]    As described earlier, the hand-held unit  1  comprises a housing, which consists of a lower housing segment  9  with lateral walls of different heights, a housing lid  10 , matched to the lower housing segment, with longitudinally displaceable locking mechanism  11 , and the two housing end lids  6 ,  7 . The lower housing segment is connected to the two housing end lids by means of tension rods or screws made, for example, of iron, some of which are screwed directly into the base block  8 . The housing is approximately 200 mm in length, the housing end lids feature a section cross-section of approximately 40×40 mm ( FIG. 2 ). The housing lid  10  pivots around an axle  104  secured in the housing end lids  6 ,  7 ; the holes in the housing end lids are used for this purpose. The nose  12  of the locking mechanism  11  can be inserted into the depression  45  in the base block  8  to lock the housing lid. The left housing end lid  6  features, in its upper front portion, a U-shaped opening  13 , which is open at the top, for the forward-protruding portion of the biopsy needle/cutting sleeve  2 ,  3  and the guide roller  81  disposed thereon. The guide roller  81 , which is placed onto a coaxial cannula when said cannula is used, also prevents tissue fluid from penetrating into the housing. The rear housing end lid  7  features two U-shaped openings  15 ,  16 , which are open at the top. The opening  15  corresponds to the passageway  13 ; it accepts the end of the round-profile plastic component  47  placed onto the hollow biopsy needle. A nozzle  63  of the vacuum pressure-generating device  5  is placed into the opening  16  ( FIG. 2 ). 
         [0070]    Another plastic component  112  inserted into the plastic part  47  features a peg  17 , which is used to connect the connecting element  4  with the outflow nozzle  64  of the vacuum pressure-generating device  5 . The interior hollow space of the biopsy needle is continuously connected with the hollow space of the piston/cylinder arrangement and the hollow space of the vacuum pressure-generating device  5  by means of the connecting element  4 , which is also hollow. The connections are designed in such a way that air cannot penetrate into the system from the outside, nor can air escape to the outside when there is overpressure; in other words, the points of connection are designed to be airtight. The system, designed in this manner, causes the sealing element  76  to be pulled against the biopsy needle  2  when a vacuum is applied to the interior of the biopsy needle, which substantially improves sealing action, but does not negatively affect the rotational movement of the cutting sleeve relative to the biopsy needle, but, if suitably designed, does rotate the biopsy needle until the rotation is stopped by a limiting device. 
         [0071]    As  FIG. 6 , in particular, shows, a microswitch  18  is integrated into the lower end of the hole  16  in the housing end lid  7 , and its switching pin  19  protrudes into the hole. As soon as the nozzle  63  of the vacuum pressure-generating device  5  is inserted into the hole and the housing lid is closed, the switching pin  19  of the microswitch  18  is pressed downward and the microswitch  18  releases the current supply. The terminals for connecting a charging device can be installed into the holes  97 ,  98  in the housing end lid. 
         [0072]    A surface  113  for the control panel ( FIG. 7 ) with control and monitoring elements is provided on the front side of the lower housing segment  9 . The control panel  57  to be attached to the housing is designed as an independent component which, for example, is glued to the surface  113  of the lower housing segment  9 . This control panel  57  is connected to other electronic components disposed in the housing, as well as with the power supply, by means of cables. Of the electric/electronic components connected to the control panel, the circuit board disposed in the space  139  located (see  FIG. 4 ) beneath the cover  46  is especially worth mentioning. A programmable microprocessor, as well as other electronic components, is disposed on the circuit board. The microprocessor is used to control the semi-automatic process control described later on. The control panel contains, in particular, switches to operate the biopsy device and diode to control the operating process. The control key  88  for mechanically triggering the clamped clamping cradle protrudes from a depression  65  in the lower housing segment and somewhat presses out the control panel disposed above it, so that the control key can easily be felt through the foil of the control panel. 
         [0073]    In designing the control and monitoring elements, steps were taken to ensure that a distinction is drawn between the clamping process of the clamping cradle and the triggering of the clamping cradle, on the one hand, and, on the other hand, between said clamping process and performance of the biopsy, such as severing of the sample and, in particular, sample removal by means of ejection of the sample. Accordingly, the control key  88  (actuator) for the clamping cradle was placed to the right, while the clamping key  90  that triggers clamping of the clamping cradle was placed to the left. The program key  89  for completing the biopsy is centered. The control lights for reset, completion of the biopsy and ejection of the sample when the sample removal chamber is opened are also centered. When the program key  89  is pressed following insertion of the removable element  20  and following closing and locking of the housing lid, as well as automatic setting of the basic position, two functions are activated, namely sample removal and sample ejection. 
         [0074]    Following insertion of the removable elements and closing of the lid, the yellow reset diode  91  is briefly illuminated and then flashes during setting of the basic position; the reset diode is extinguished following setting of the basic position. The sample removal diode  92  (green) and the clamping diode (yellow) are illuminated and indicate that the operator can activate one of the two functions. If he presses the clamping key  90 , the clamping cradle  28  is brought into clamping position and locked in this position. To prevent the clamping key from being pressed inadvertently, it is equipped with a delay circuit of about 1.2 seconds. The yellow clamping diode blinks during the clamping process. Following completion of the clamping process, the locking diode (green) blinks. The device, i.e., the biopsy needle, is then ready to be shot into the tissue to be examined and is triggered by means of the control key  88 . Following the shot into the tissue, the locking diode is extinguished and the clamping diode (yellow) and the sample removal diode (green) are illuminated. Both functions (clamping or sample removal) can now be activated. 
         [0075]    When the program key  89  is pressed, the biopsy process is performed automatically, as explained later on. However, the clamping process could also be activated again. When the biopsy process (sample removal) is activated, it takes place automatically. Following completion of the process, the flashing green sample removal diode is extinguished and the yellow ejection diode is illuminated. When the program key is pressed again, the automated sample removal process is performed. Following completion of the process, the flashing ejection diode is extinguished and the yellow reset diode is illuminated, which means that the removable element  20  can be removed, or that it can be automatically prepared for removing an additional sale by pressing the program key. This is followed by process as described above, i.e., either clamping or sample removal. For the event that the program key  89  is pressed for sample removal (to eject the sample), a delay circuit is provided that prevents ejection from occurring if the program key is touched inadvertently before the needle has been removed. 
         [0076]    The battery charge diode  96  indicates the charging condition of the battery or storage battery. As described earlier, the diodes are wired in such a way that the diode flashes during completion of the specific process that was activated, and that the diode for the ensuing process is illuminated following completion of the process. If two options are available, both subsequent diodes are illuminated. In this case, the operator may select the option of his choice. The colors of the diodes are selected in such a way that procedures in the tissue are indicated by a green light, while external procedures are indicated by a yellow light. Delay circuits (e.g., 1.2-1.5 seconds) are provided for the functions or clamping and sample removal, so as to ensure that the process is activated deliberately. The mode of action and control options are discussed in greater detail during the description of the process sequence. Symbols (pictograms) on the board symbolize the individual processes. 
         [0077]    A perspective view of the base block  8  (as seen from the front in the direction of the x axis) is shown in  FIG. 8 a   , while  FIG. 8 b    depicts the base block  8  from behind in the x-axis (both are perspective views). The base block  8 , when viewed in a longitudinal direction, can be divided into two halves; the front section is used to secure the common drive for the cutting sleeve and the clamping cradle and, in its front portion, to support the biopsy needle carrier ( FIG. 8 a   ); the rear section is used to secure the drive for the vacuum pressure-generating device  5  as well as the support for the distal side of the vacuum pressure-generating device  5  ( FIG. 8 b   ). A central electronics circuit board is disposed between the two drive motors  21 ,  58 , below the center rib  87 , in the space  139  beneath (see  FIG. 4 ). The base block  8  features, in its left, front portion, a U-shaped space  24 , in which a toothed roller  23  driven by the geared motor  21  is installed. To this end, the drive shaft of the geared motor is supported and/or inserted in an opening in the wall  25  of the base block  8 . The toothed roller  23  is mounted onto the drive shaft and is attached to it and secured against rotation and displacement by means of a screw. On the other side, the toothed roller  23  is supported in the wall  22  of the base block  8 . A DC motor with a rotation speed of approximately 11000 RPM is used as the drive motor. A planetary gear with high gear reduction is installed downstream from the DC motor, with the toothed roller  23  mounted on its drive shaft. 
         [0078]    Molded to the wall  22  and pointing to the right is another block  26 , which both accepts the pivoting double-armed handle  33  for the locking mechanism and serves to secure the pin  30  guiding the clamping cradle  28 . The pins  30  are screwed into the threaded bore  29 . During the clamping process, the clamping cradle  28  slides to the right on the divider plate  114  disposed below it. During the clamping process, the spiral spring  31  disposed on the threaded pin  30  is compressed. One end of the spiral spring rests against an end piece  32  of the threaded pin or directly on the housing end lid  7 ; the other end of the spiral spring, which protrudes into a blind hole in the clamping cradle, rests against ship resting on a lip  122  of the guide hole  115 . The threaded pin  30 , secured to the housing end lid  7  at one end and to the block  26  at the other, carries at its distal end a short spiral spring  124 , which also rests, on its proximal side, against another shim  125  resting against the circumferential lip  122  in a coaxial blind hole  129  opposite the hole  115 . Both spiral springs have the same diameters, and the diameters of the distal and proximal bore  129 ,  115  in the clamping cradle and the distal bore  128  in the block  26  are such that the spiral springs can be easily inserted. All bores are coaxial to the pin  30 . The threaded pin  30  features a band  123  at the same axial distance to the circumferential lip in the blind hole of the cradle. In its starting position (resting position), the clamping cradle  28  is held in resting position by slightly loaded springs  31 ,  124  over the shims, as depicted in  FIGS. 3 a    and  3   c.    
         [0079]    The shims rest against both the corresponding side of the band and the lip, and are vertically disposed. Thus, if the cradle is deflected to the right or left, the respective spring will attempt to return the clamping cradle to its starting position; in a manner of speaking, the clamping cradle is “swimming.” The clamping cradle  28  slides on the divider plate  114 , in particular, and is prevented from rotating by said cradle and by the side wall. An arm  99  of the double-armed handle  33  of the locking device engages a groove  27  of the clamping cradle  28  ( FIGS. 9 a  and 10 a   ). The locking device integrated into the block  26  of the base block  8  consists of a double-armed handle  33 , which pivots around a vertical axis (seen in the y axis) by means of a compression spring  34 . The axis  35 , a vertically disposed pin, is secured in the bores  38  of the base block. In the resting state, the part  99  of the double-armed handle lies in the groove  27  of the clamping cradle; the compressed spring  34  acts on the part  100  of the handle and presses the locking key  88  outward (toward the front). The locking key is easily felt in the control panel, which is pushed slightly outward at this point after clamping. 
         [0080]    As soon as the part  99  of the double-armed handle can lock into the depression  82  in the clamping cradle, the control key  88  is pushed outward. As a result of the locking of the handle part  99 , the clamping cradle is locked in the clamping state and can be triggered, if needed, by pressing the control key  88 . As the clamping cradle is advantageously made of plastic, it has proven to be advantageous to place a metal part  83  into the depression so as not to damage the plastic, as the double-armed handle is also made of metal. In contrast to the removable element  20 , the hand-held unit  1  with replaceable insert is reused several times. The clamping path corresponds to the depth of penetration of the biopsy needle into the tissue. Consequently, the length of the handle  99  also corresponds to the clamping path. As the depth of penetration generally ranges between 15 and 25 mm, the same hand-held unit  1  can be used for various depths of penetration by suitably designing the handle  99  and modifying the settings in the control unit accordingly. 
         [0081]    The clamping cradle  28 , which is adjacent to the block  26 , is disposed at the same height as the block  26 , and has approximately the same profile as the block  26 . The clamping cradle features two brackets  40  on its upper side. The upward-facing surface  41  of the clamping cradle, the upward-facing surface  44  of the block  26 , and the upward-facing surface of the extension  42  of the base block  8  together form a flat support surface for the lower sliding surface  43  of the biopsy needle carrier  37  to be mounted (see  FIG. 2 ). The biopsy needle carrier is made of plastic. When the clamping cradle is shifted from its non-tensioned resting state ( FIG. 9 a   ) to its clamped state ( FIG. 10 a   ), i.e., to the right, the biopsy needle carrier  37  held by the brackets  40  slides across the surface  42  and  44 . It is also conceivable that the sliding surfaces are not flat, as in the exemplary embodiment, but feature uniquely structured sliding surfaces; what is important is that the biopsy needle carrier  37  can slide easily and in a straight line on the sliding surface, and that, once the control key  88  has been triggered, the biopsy needle can penetrate into the tissue, the tumor, in a straight line. For this reason, the upper outside contour of the biopsy needle carrier is also shaped to conform to the inside contour of the housing lid and features only a small amount of play to the housing lid, so as to prevent upward deflection of the biopsy needle, which is also advantageous during the clamping process. 
         [0082]    Above the U-shaped space  24  for the toothed roller  23 , at the level of the sliding surface  42 , the base block  8  has a U-shaped holding device  36 , which is open to the top, for inserting the biopsy needle/blade sheath, among other things. The primary function of this holding device is that of a radial thrust bearing, i.e., it supports the drive part that is connected to the blade sheath, namely the gear  74  or the plastic disk  78 , in order to bring the clamping carriage into its clamped position by means of the drive device  106 . On the distal side, the holding device also serves as a stop for the collar  127  in the execution of the back-and-forth movement and the associated angular-rotation movement. 
         [0083]    A further U-shaped insertion element  62  is provided in the rear, upper part of the base block; the free end  61  (distal end) of the threaded spindle of the vacuum- and pressure-generating device  5 , the end protruding from the syringe body, is inserted into the insertion element. The insertion element is embodied as a conduit, in which the threaded spindle  53  slides. In the upper, central region of the base block, a fastening device is provided for a disk that is received by the recess  45 ; the latch  12  of the locking bar  11  of the housing lid is pushed into the fastening device. A cover  46 , which is disposed on the base block  8  and faces left, separates the space for the drive motors and the inserted plate from the upper, left portion of the housing interior, which primarily serves in seating the replaceable biopsy-needle carrier  37 , including the biopsy needle and the blade sheath. The cover  46  protects the electrical gear motors and the plate from contamination. The plate for the electronic components lies between the drive motors, and beneath the center rib in the space  139  (see  FIG. 4 ).  FIG. 2  illustrates the biopsy-needle carrier  37 , which can be inserted into the brackets  40  of the clamping carriage  28  with the biopsy needle  2  and the blade sheath  3 , as well as further parts. 
         [0084]    The hollow, circular biopsy needle  2  has a needle tip  70 , which the specimen-collection chamber  71  adjoins ( FIGS. 11 a -11 f   ). The biopsy needle  2  having a round cross-section is surrounded coaxially by a blade sheath  3 , also having a round cross-section, and having at its left end, which faces the specimen-collection chamber  71 , a blade  72 . In an especially preferred embodiment, after the biopsy needle has been inserted (with the specimen-collection chamber  71  being closed) and the specimen-collection chamber  71  has been opened, and the needle has performed a repeated back-and-forth movement that is superimposed simultaneously by a predetermined, limited angular-rotational movement of the biopsy needle about its longitudinal axis, the blade serves in cutting out the specimen and holding it in the closed specimen-collection chamber  71 , as will be explained in detail below. The distal blade of the blade sheath is preferably disposed perpendicular to the longitudinal axis of the biopsy needle and the blade sheath. 
         [0085]    The severing procedure is preferably effected through the rotation and simultaneous longitudinal displacement of the blade sheath by the threaded-spindle drive. It is also conceivable for the blade sheath not to execute a continuous movement, but for it to move in increments or to vibrate, i.e., the traveling part is moved forward and back by short distances. As can especially be seen from the cross-sectional representation in  FIG. 11 f   , the longitudinal edges  68  of the specimen-collection chamber  71  are located above the center point of the cross-section—in other words, the specimen-collection chamber  71  extends beyond the Z-axis by about 15-30°. To improve the entrance of solid, hard tissue into the specimen-collection chamber  71 , the longitudinal edges have a blade. This blade at the longitudinal edges is created through the reduction of the wall thickness from above such that the width b′ at the cutting edge corresponds to the width b of the diameter of a lower-lying blade-sheath-tube, i.e., the wall thickness is reduced in the upper part and utilized to embody the cutting edge ( FIG. 11 f    and enlarged view in  FIG. 11 g   ). 
         [0086]    At the other, proximal end of the blade sheath, which faces away from the blade  72 , a threaded-spindle sheath  73  is secured to a gear  74  that is disposed at the end face of the threaded-spindle sheath. The threaded-spindle sheath is disposed with the gear on the blade sheath so as to be fixed against rotation and displacement. A threaded-spindle nut  75  that is pressed securely into the biopsy-needle carrier  37  cooperates with the threaded spindle. The gear  74  is to the left, that is, in front of the beginning of the spindle sheath. When the threaded-spindle sheath is rotated by the gear  74 , the blade sheath is rotated and displaced longitudinally over the biopsy needle  2 . 
         [0087]    On the distal side of the gear  74 , a tubular piece  126  having the collar  127  is permanently connected to the threaded spindle. The tubular piece is inserted into the holding device  36 , with the collar  127  being located on the distal side in front of the holding device. The length of the tubular piece  126  approximately corresponds to the clamping path; the wall thickness of the holding device  36  must additionally be considered here ( FIGS. 3 a  and 3 b   ). In the initial position of the device (closed specimen-collection chamber  71 ), the collar  127  travels to the left, to the distal side, whereas it comes to rest against the holding device  36  (distal side) after the specimen-collection chamber  71  has been opened. As the spindle sheath continues to rotate with the blade device, that is, in the attempt to open the specimen-collection chamber  71  wider, the clamping carriage is pulled toward the block  26 , counter to the effect of the short coil spring, because the collar  127  rests against the holding device  36  on the distal side. Consequently, as will be described further below, the biopsy needle can be set into a back-and-forth movement that is superimposed by a limited angular-rotational movement of the biopsy needle to both sides. This angular-rotational movement is effected by the attempt of the blade sheath to carry the biopsy needle along in the rotation; the needle, however, is prevented from rotating past a predetermined angular rotation, as can be seen particularly in  FIGS. 12 b    through  12   d.    
         [0088]    The gear  74  at the left end of the threaded spindle meshes with the toothed roller  23  after the biopsy-needle carrier has been inserted into the brackets  40 . To allow the biopsy-needle carrier  37  to be inserted into the brackets of the clamping carriage when the carriage is not clamped ( FIG. 2 ), the biopsy-needle carrier has two planar, parallel recesses  77  ( FIG. 2 ). When the sliding surface of the biopsy-needle carrier  37  is placed onto the surfaces  41 ,  42  and  44 , the biopsy needle is simultaneously inserted into the holding device  36  of the base block  8 . On the left side of the gear, a slightly conical plastic disk  78  can be incorporated in order to improve the rotating capacity of the spindle drive, especially if the holding device  36  is serving as a support for clamping the clamping carriage. When the biopsy-needle carrier is inserted correctly, the carrier slides to the right, with the sliding surface  43 , across the surfaces  42  and  41  as the clamping carriage is clamped. Because the specimen-collection chamber  71  is closed after the biopsy-needle carrier has been inserted, the gear  74  rests against the holding device  36 . 
         [0089]    If the toothed roller  23  is driven further in the same direction, the threaded-spindle drive screws the clamping carriage to the right, by way of the biopsy-needle carrier, until it is latched; in the process, the biopsy needle is retracted, while the blade sheath remains in its position. The blade sheath protrudes past the tip of the biopsy needle after the latching procedure. Therefore, after the clamping carriage has been latched, the blade sheath is rotated back into the initial position (opposite direction of rotation); the gear  74  is displaced from the left to the right in the toothed roller. After the clamping carriage has been unlatched, the biopsy needle and the blade sheath with the gear slide to the left again with the biopsy-needle carrier. Now the blade sheath can be displaced to the right again in order to open the specimen-collection chamber  71  until the collar  127  comes into contact. The function of the “floating” seating of the clamping carriage in connection with the controllable drive motor and the tubular piece  126  connected to the blade sheath and having the collar  127  is explained in greater detail in connection with the biopsy procedure. 
         [0090]    A sealing element  76  produces a connection between the right end of the blade sheath and the hollow biopsy needle that permits rotation, but is airtight, so that air cannot enter between the biopsy needle and the blade sheath surrounding it coaxially, and air cannot exit under overpressure conditions. The sealing element  76  comprises a plastic hose that is pulled over the proximal end of the blade sheath. The inside diameter is selected such that it rests lightly against the outside diameter of the biopsy needle. When a vacuum is generated in the interior of the biopsy needle, and thus between the biopsy needle (outside) and the blade sheath (inside), the elastic plastic hose is pulled against the outside diameter of the biopsy needle. Provided that the biopsy needle is rotated relative to the blade sheath, the hose can serve as a restoring element (restoring spring). For rotating the biopsy needle slightly by means of the blade sheath, the biopsy needle is slightly deformed in the region of the sealing element  76 , so it is oval-shaped at the deformed point  0  ( FIG. 12 f   ). When the blade sheath rotates, the biopsy needle is carried along by the deformation  0  until the rotation of the needle is limited by a stop ( FIGS. 12 b  through 12 d   ). 
         [0091]    This angular-rotational movement of the biopsy needle simultaneously effects the pivoting of the sharpened longitudinal edges of the biopsy-needle space to both sides about the longitudinal axis of the biopsy needle. Because this angular-rotational movement is effected by the same drive and occurs simultaneously with the back-and-forth movement of the biopsy needle, the cutting edges of the specimen-collection chamber  71  sever the tissue, in the manner of a driven knife, both longitudinally in the X-axis and with an angular offset, so the tissue, which is under pressure (external and/or internal pressure) reliably enters the open specimen-collection chamber  71 .  FIG. 12 f    illustrates the specimen-collection chamber  71  in the neutral initial position after opening,  FIG. 12 g    shows the position following an angular rotation to the right by the angle α, and the simultaneous retraction of the biopsy needle by the distance X 1  (about 2 mm) to the proximal side;  FIG. 12 h    shows the position of the biopsy needle during a rotation to the left by the angle β, and the simultaneous movement of the biopsy needle to the distal side by the distance X 2  (about 2 mm). The movement of the cutting edges of the specimen-collection chamber  71  or the biopsy needle ensures that the tissue will be severed at the longitudinal edges, regardless of the tissue structure. The described movement of the biopsy needle, and therefore of the sharpened longitudinal edges of the specimen-collection chamber  71 , also ensures that the severed piece of tissue will enter the specimen-collection chamber  71 , even if the pressure that is normally exerted is absent. 
         [0092]    A round, hollow plastic part  47  is placed onto the right end of the biopsy needle  2  in a frictional, airtight connection. At its left end, the plastic part  47  has a bearing element  49 , which is pressed into the biopsy-needle carrier; at its right end, which protrudes from the hand piece, a further plastic part  112  is provided. This part can rotate relative to the plastic part  47  and the biopsy needle  2 . An O-ring is inserted between the biopsy needle and the plastic part  112  to assure a seal. At its right end, the plastic part has a tappet  17 , onto which the connecting element  4  is pushed to form an airtight connection. Also disposed at the right end protruding out of the biopsy-needle carrier and the housing is a knurled knob  80 , which can be rotated to adjust the position of the specimen-collection chamber  71  radially without altering the position of the blade sheath. Only a single rotation of the specimen-collection chamber  71  is associated with a rotation of the biopsy needle. The plastic part  47  is pressed, with the biopsy needle, the blade sheath, the bearing element  49  and the threaded-spindle nut  75 , into the biopsy-needle carrier. By way of the bearing element  49  and its narrow guide in the blade sheath, the biopsy needle is seated to rotate in the biopsy-needle carrier and in the blade sheath, and to be displaced with the biopsy-needle carrier along the longitudinal axis. As explained above, the blade sheath can be rotated axially relative to the biopsy needle. 
         [0093]    To the right of the bearing element  49 , a polygonal member  50  is disposed on the plastic part  47 . The polygonal member can be clamped to latch with the biopsy-needle carrier  37 , so the specimen-collection chamber  71  of the biopsy needle can be brought into and held in the position that is most favorable for the biopsy collection by means of the knurled knob  80 . During the rotation, the two legs  39  of the biopsy-needle carrier, which comprises an elastic plastic, are spread by the corners of the polygonal member until the surfaces of the polygonal member are nearly perpendicular to the legs  39  again, and the polygonal member is latched again ( FIG. 12 c   ). The polygonal member is then adjusted by a predetermined increment. If the polygonal member is hexagonal, the rotational distance is 60°; if more rotational increments are desired, a polygonal member having 8, 10, etc., sides should be selected accordingly. 
         [0094]    As can be seen particularly in  FIGS. 12 b  through 12 f   , the biopsy-needle carrier has two legs  39 , which are connected to one another by a cap element  116 . In the plastic carrier, the polygonal member  50  of the plastic part is seated to be latched: The legs  39  connected to the elastic fastening element are first spread apart during a rotation in order to return to their initial position due to the elasticity. If the inscribed circle diameter S selected for the polygonal member is smaller than the distance A (clear width) of the two legs from one another, the biopsy needle can rotate slightly to both sides about its axis, by a predetermined angle (α or β) ( FIGS. 12 b -12 d    illustrate the center position). The legs  39  of the biopsy-needle carrier are not spread here; on the contrary, they prevent the biopsy needle from rotating by a larger angle, because the drive is configured such that the blade sheath can be rotated further, but the resistance of the leg limit is greater than the drive moment. The corners of the polygonal member impact the legs  39 , and prevent a further rotation, because the torque acting on the biopsy needle does not suffice to spread the two legs. Because the plastic part  47  with the polygonal member is permanently connected to the needle, and the blade sheath was pushed onto the deformed region  0  of the biopsy needle when the specimen-collection chamber  71  was opened, and the sealing element  76  enters a frictional connection with the outside of the biopsy needle when the specimen-collection chamber  71  is open, when the blade sheath is driven in a respective direction of rotation, the biopsy needle also rotates about its axis due to this frictional connection until the stop effected by the polygonal member prevents a further rotation in the absence of a greater torque. 
         [0095]    Because the vacuum that dominates in this phase pulls the elastic sealing element more strongly against the outside surface of the biopsy needle, the sealing element facilitates the rotation of the blade sheath relative to the biopsy needle, on the one hand; on the other hand, the sealing element acts as a restoring element if lightly touched. This limited rotational movement is understood to be an angular-rotational movement. The biopsy needle, which can rotate to a limited extent, ceases its angular-rotational movement due to the change in the direction of rotation, and returns to its initial position because of the twisted sealing element, then is rotated in the other direction counter to the effect of the elastic sealing element. Generally, about one rotation of the gear  74  in each direction (about one rotation from the zero position) suffices for the limited angular-rotational movement in connection with the back-and-forth movement, as described above. When the gear rotates, the biopsy needle is displaced from the zero position by about 2 mm to the left or right, and is simultaneously moved about the longitudinal axis by the angle α or ( 3 . Generally, this movement is repeated about five times in each direction. 
         [0096]    As shown particularly in  FIG. 12 , the blade sheath surrounding the biopsy needle coaxially is connected to the biopsy-needle carrier  37  by way of the threaded-spindle nut  75 . The threaded-spindle sheath  73  is seated so as to rotate in the threaded-spindle nut  75 . A rotation of the gear  74  by the drive motor of the toothed roller  23  causes the biopsy-needle carrier and the clamping carriage to be moved to the right as soon as the gear  74  comes into contact with the holding device  36 . When the gear occupies a position within the length of the toothed roller  74 , that is, provided that the gear is free and does not rest against the holding device or the threaded-spindle nut  75 , the blade sheath can be adjusted alone, for example after the biopsy needle has been clamped, in order to align the needle tip and the blade sheath for returning the blade sheath to the initial position, or for opening and closing the specimen-collection chamber  71 . 
         [0097]    When the specimen-collection chamber  71  is opened, the blade sheath is pushed over the slightly deformed region  0  of the biopsy needle. In this position, as the blade sheath continues to rotate, the biopsy needle is carried along in the direction of rotation by a predetermined angle; because the connection between the blade sheath and the biopsy needle only permits the transmission of a predetermined torque, however, the rotational movement of the biopsy needle comes to a halt when the corresponding corners of the polygonal member come into contact with the legs of the biopsy-needle carrier ( FIGS. 12 b  and 12 d   ). The tubular piece  126  with the collar  127 , which is mounted to the distal side of the gear, and cooperates with the holding device  36 , serves in setting the needle into a brief vibrating movement (back-and-forth movement), in cooperation with the control, and in simultaneously setting the biopsy needle into an alternating angular-rotational movement, as described above. 
         [0098]    Because the vibrating (back-and-forth) movement is effected by the drive for the blade sheath  3 , the connection of the blade sheath to the deformed point  0  of the biopsy needle and the configuration of the polygonal member  50  and the biopsy-needle carrier simultaneously effect a limited rotation of the biopsy needle in both directions of rotation (depending on the direction of rotation), which is superimposed over the back-and-forth movement of the biopsy needle. These two combined movements sever any type of tissue with the cutting edges of the specimen-collection chamber  71 . The tissue, even if it is tough or has inclusions, can be reliably pulled or inserted into the specimen-collection chamber  71  with or without pressure. The aforementioned vibrating (back-and-forth) movement of the biopsy needle, which also effects the angular-rotational movement, is described below: 
         [0099]    When the toothed roller is driven, the gear  74  opens the specimen-collection chamber  71  until the collar rests against the distal side of the holding device  36 . If the same direction of rotation is maintained, and the gear no longer rests against the threaded-spindle nut, the further rotation causes the clamping carriage to be pulled over the biopsy-needle carrier toward the block  26 , counter to the effect of the short coil spring, because the contact of the collar  127  with the distal side of the holding device  36  makes it impossible for the blade sheath to be opened further. The clamping path or the movement path (X 1  or X 2 ) is about 2 mm, or corresponds to about one rotation of the blade sheath. 
         [0100]    When the gear  74  stops against the threaded-spindle nut, the direction of rotation of the motor is reversed and, with the support of the short coil spring, the clamping carriage returns to its initial position (resting position), and the biopsy needle is rotated back into its zero position. Because a detector counts the motor rpm, and the actual values are stored in a programmable microprocessor, corresponding preset commands can be used to change the direction of rotation of the motor, so the clamping carriage is pulled toward the block again or retracted after being released. The continuous reversal of the motor&#39;s direction of rotation, as specified in advance, works in conjunction with the clamping and release of the carriage to effect a back-and-forth movement of the biopsy needle that is superimposed with a limited angular-rotational movement of the biopsy needle to both sides, depending on the direction of rotation. Five back-and-forth movements typically suffice to assure a good specimen collection, even of tough tissue or tissue having inclusions, such as calcification. The back-and-forth movement of the biopsy needle, in conjunction with the limited angular-rotational movement of the needle, and the sharpened cutting edges, severs the tissue, which has been pulled to the specimen-collection chamber  71  by a vacuum, for example, at the side edges in order to permit or greatly facilitate the entrance of the specimen into the specimen-collection chamber  71 , even if the specimen comprises tough tissue. 
         [0101]    The described movement of the biopsy needle, and thus of the sharpened longitudinal edges of the specimen-collection chamber  71 , permits a superior severing of the tissue after or during the opening of the specimen-collection chamber  71 . The same good tissue-severing action can be attained if this vibrating movement or angular-rotational movement is performed during the opening process, that is, when the blade sheath is retracted.  FIGS. 12 g  and 12 f    illustrate this superimposed movement of the biopsy-needle space in detail, in the phases of left and right rotation as well as the zero position.  FIG. 12 g    and others depict the initial position: The biopsy-needle space is open, the blade sheath is retracted by about 2 mm past the proximal edge of the specimen-collection chamber  71 , and the polygonal member is in the neutral position ( FIG. 12 c   ). In the representations of  FIGS. 12 h  and 12 g   , the biopsy needle is retracted into the blade sheath, and the needle is simultaneously pivoted by the angle α.  FIGS. 12 f  and 12 d    show the other direction of rotation, and the rotation by the angle β. The proximal edge of the biopsy-needle space is displaced by about 2 mm toward the distal side relative to the initial position, and is simultaneously pivoted by the angle β in the other direction.  FIGS. 12 g , 12 f  and 12 b  through 12 d    illustrate a cycle that is repeated several times—typically five times—under the control of the microprocessor. This back-and-forth movement and the limited angular-rotational movement can be effected by electrical elements that are connected to the needle or the clamping carriage. 
         [0102]      FIGS. 11 a  through 11 g    illustrate details about the specimen-collection chamber  71  and the embodiment of the biopsy-needle tip. Approximately 25% of the cross-section of the specimen-collection chamber  71  adjoining the needle tip  70  is open to the top. For example, if the biopsy needle has an outside diameter of 3.3 mm, the height H of the specimen-collection chamber  71  is about 2.3 mm. The specimen-collection chamber  71  is approximately between 15 and 25 mm long. Adjoining the chamber is the hollow space of the biopsy needle. At the transition, that is, at the proximal end of the specimen-collection chamber  71 , the cross-section of the hollow space of the biopsy needle is closed by between 50% and 75% by a narrowed region, such as a stopper  79  ( FIGS. 11 b  through 11 e   ). The height of the stopper is selected such that the stopper extends downward past the recess for the specimen-collection chamber  71 . 
         [0103]    As can be seen in  FIG. 11 e   , an opening F is provided in the floor of the specimen-collection chamber  71 ; if the inside diameter of the needle is 3.0 mm, the height of the opening is 0.6 mm. The vacuum is intended to pull the tissue specimen into the specimen-collection chamber  71  as the chamber is continuously opened, and bring the specimen into contact with the wall of the chamber. If an overpressure is present in the biopsy-needle hollow space, the narrowed region, the stopper, increases the pressure. The stopper is about 10 mm long, and is glued or welded into the hollow space. The use of laser welding has revealed that it is advantageous to construct the left side of the stopper by removing material at the end face to make it short, namely about 2 mm long. Consequently, in this region at the end face, the tube of the biopsy needle is welded completely to the end face of the stopper, and is airtight at the end face. The stopper can also be shorter, provided that the same effect is attained. The stopper can also be replaced by a lip or a latch of approximately the same height. 
         [0104]    It is critical that the narrowed region be embodied to allow the vacuum in the specimen-collection chamber  71  to be effective from the floor, so that the specimen sticks to the wall of the chamber as the blade sheath is closed, that is, during the cutting process, and does not change its position. It has also proven advantageous to provide additional securing means on the specimen-collection wall. Sucking the specimen into the specimen-collection chamber  71  from below results in a high filling capacity of the specimen-collection chamber  71 , on the one hand, and the configuration of the chamber, in particular, allows the specimen to be secured well to the wall, on the other hand. For this reason, it is crucial that the lateral severing of the tissue through the described movement of the sharpened longitudinal edges of the specimen-collection chamber  71  ensures that the tissue reaches the chamber floor. 
         [0105]    Because the blade sheath severs the specimen on the outside of the biopsy needle, the process of suctioning the specimen in the inside is also maintained during a severing process, if possible. The outside location of the blade sheath, and the fact that the tissue sticks to the inside floor of the specimen-collection chamber  71 , prevent the specimen from being rotated or twisted by the rotating longitudinal movement of the blade sheath during the closing process. The quality of the specimen is greatly improved over systems that employ a twisting effect. The pathologist obtains a starting material whose cross-section corresponds to the section in the tissue, not a twisted or deformed mixture of tissues. Ejecting the specimen under pressure is a reliable method of depositing it. The stopper  79  permits this. In addition, the specimen-collection chamber  71  is completely cleaned, so if the biopsy is repeated, there is no mixing of tissue specimens (residual particles). 
         [0106]    Because the vacuum-generating device is simultaneously used as a pressure-generating device, the entire hollow space, particularly the biopsy needle, is cleaned during the ejection process. For normal tissue, it suffices to use the wall thickness of the biopsy-needle tube, which is about 0.15 mm, as a lateral cutting edge. For hard and/or tight tissue, the filling capacity achieved in the specimen-collection chamber  71  solely through vacuum suction is insufficient, because the tissue at the side edges is not adequately severed. Through the embodiment of the long sides of the specimen-collection chamber  71  as cutting edges  68 , as can be seen particularly in  FIGS. 11 g  and 11 f   , the superimposing of a repeated back-and-forth movement and a limited, repeated angular-rotational movement of the biopsy needle with the specimen-collection chamber  71  to the left and right (as described), as well as the pressure effect of, for example, an internal vacuum, for example with the ultrasonic head, the specimen tissue is severed longitudinally, so the specimen travels to the floor of the specimen-collection chamber  71  far better because of the vacuum or external pressure. The exertion of an external pressure or an internal vacuum in the biopsy-needle hollow space can reinforce the cutting effect of the longitudinal edges. 
         [0107]    Severing the long-side cutting surfaces of the tissue specimen to be removed through the movement of the needle attains a superior filling capacity, even with hard and/or leathery tissue or tissue having inclusions. This method provides adequate tissue material for testing. The cutting edge at the long side of the specimen-collection device is formed by the milling off of the partial piece (T 1 ) from the wall thickness ( FIG. 11 g   ). The diameter (ra) of the outside contour of the biopsy-needle tube is retained, while the inside diameter (ri) of the inside contour changes over to the outside contour, via a perpendicular wall, through the milling out of the partial piece (T 1 ) ( FIG. 11 g   ).  FIG. 11 d    shows the closed specimen-collection chamber  71 , in which the collected specimen is located. During the severing process, it has proven advantageous to move the blade sheath  78  out of its end position, shown in  FIG. 11 d   , and about 2 mm in the distal direction, and then retract the blade sheath by these 2 mm into its end position. This shearing effect reliably severs fibers that may not yet be completely severed, which further increases the quality of the specimen. 
         [0108]    The biopsy needle described here operates with a vacuum that is generated internally. The back-and-forth movement combined with the superimposed, limited angular-rotational movement of the biopsy needle, and thus of the blades of the specimen-collection chamber  71 , also produces superior results in biopsy needles without a vacuum or if the vacuum fails, especially if, for example, an external pressure is exerted onto the tissue in the biopsy hollow needle, such as through ultrasound, instead of the internal vacuum. Using only the angular-rotational movement, superimposed with the back-and-forth movement of the needle in conjunction with the long edges of the specimen-collection chamber  71  embodied as blades, however, considerably improves the tissue-severing process and facilitates the entry of the tissue specimen to be cut out into the specimen-collection chamber  71 . It must also be pointed out that the elastic sealing element is not required as a restoring element in every case; merely reversing the direction of rotation can effect the restoring action. 
         [0109]      FIG. 13  shows the drive and the installation of the vacuum- and pressure-generating device  5  (view from behind, that is, along the Z-axis; housing lid and lower housing part omitted). In the upper, rear, right region, the vacuum- and pressure-generating device  5  is embodied as a plunger/cylinder unit  69 . It comprises a syringe body  52  having a threaded spindle  53  inside it; at its end facing the bottom  51  of the syringe, a plunger  54  with sealing elements—a standard feature of syringes—is secured to the spindle ( FIGS. 14 a  through 14 d   ). At the end of the syringe body  52  facing the base block  8 , a threaded-spindle nut  48  having a gear  55  at its circumference is disposed on the threaded spindle. The threaded-spindle nut has one or more thread turns. The threaded spindle  53  cooperates with the threaded-spindle nut  48 . The spindle has a pitch of about 5 mm per turn, so with each rotation by means of the spindle drive, the plunger moves by a precisely defined distance out of the syringe body, that is, away from the bottom  51  of the syringe, or toward the bottom of the syringe, depending on the direction of rotation. 
         [0110]    The gear rim  55  disposed at the circumference of the threaded-spindle nut meshes with the drive pinion  56 , which is secured to the power takeoff shaft of the DC gear motor  58 . The power takeoff shaft of the DC gear motor  58  is seated in the base block  8 ; for this purpose, the power takeoff shaft is inserted into the transverse plate  59  of the base block. When the DC gear motor  58  is activated, the plunger is moved toward the bottom of the syringe, or in the direction of the base block  8 , depending on the direction of rotation. A DC motor having a high rpm is used as the drive motor; a planetary gear having a high step-down is disposed downstream of the DC motor. The motor corresponds to the motor described above for the clamping device. Hence, a counting device, comprising a two-armed blade wheel  131  and a photocell that is mounted to the motor side, is likewise secured to the distal side of the DC gear motor. The counting device is connected to the programmable microprocessor, so the function of the vacuum- and pressure-generating device can be controlled with the rpm: After an initial value has been ascertained, the functions can be called up with programmable or programmed specifications. 
         [0111]    The plunger  54  is embodied in a known manner as a syringe plunger. The plastic syringe body, a cylinder with a floor, is transparent. To prevent the threaded spindle  53  from rotating when the threaded-spindle nut is driven, the two oppositely located surfaces  60  of the threaded spindle are planar ( FIG. 14 d   ). The threaded spindle is inserted into the insertion element by its free end. The spacing of the threaded-spindle surfaces corresponds to the width of the U-shaped insertion element  62  of the base block  8 . Only a small amount of play exists between the U-shaped cross-section of the insertion element and the spindle surfaces on both sides. The threaded-spindle nut is supported on the base block. To prevent the syringe body  52  from sliding out when the threaded-spindle nut rotates, the contact surface of the base block  8  has a slightly conical shape at the bottom. The connector  63  of the syringe body  52  is inserted into the passageway  16  of the housing end lid  7  such that the syringe body is held in an approximately horizontal position. 
         [0112]    To make the rotation of the threaded spindle smooth, the threaded-spindle nut with the gear rim has an approximately 1.5-mm thick phase  66  ( FIG. 14 c   ) on the side facing the base block. Because the surface of the rib  59  on the base block  8 , which cooperates with the phase  66  of the threaded-spindle nut  48 , is inclined from top to bottom, the vacuum- and pressure-generating device  5  is pulled down during operation. To generate a sufficient vacuum of about 200 hph in the specimen-collection chamber  71 , if the biopsy-needle length is about 250 mm and the inside diameter of the biopsy hollow needle is between 3 and 5 mm, a 20-ml syringe body having a length of about 90 mm is used. To also be able to use the syringe body to generate pressure, a ventilation bore  67  having an approximately 1.5-mm diameter is provided after about ¾ of the length, corresponding to the stroke for generating the vacuum (position according to  FIG. 11 b   ). The ventilation bore can also be embodied as an oblong slot. 
         [0113]    When the vacuum is no longer required, and the syringe plunger is moved past the ventilation bore  67  ( FIG. 14 c   ), the supply of air (atmospheric pressure) via the ventilation bore  67  reduces the vacuum that was previously built up in the biopsy hollow needle. If the direction of rotation of the gear motor is then reversed, the depression of the plunger (toward the bottom of the syringe) causes the vacuum- and pressure-generating device to effect the buildup of an overpressure in the system, so the specimen is ejected after the specimen-collection chamber  71  is opened. To prevent tissue fluid from escaping during the brief opening of the ventilation bore  67 , the ventilation bore may be covered with an air-permeable sponge (not shown), for example. A delay circuit that is integrated into the control mechanism prevents the tissue specimen from being ejected through the inadvertent depression of the programming key  89 ; the delay circuit only initiates the procedure after the key has been held down for about 1.2 to 1.5 seconds. The specimen cannot be ejected until the biopsy needle has been removed from the tissue. Moreover, the compressed air not only cleans the specimen-collection chamber  71 , but particularly the interior of the biopsy needle as well. 
         [0114]    The stopper that narrows the needle hollow space impedes or completely prevents the entry of tissue segments into the biopsy-needle hollow space. The narrowing of the needle hollow space by the stopper  79  increases the pressure at the specimen-collection chamber  71 , and therefore improves the ejection of the specimen when the specimen-collection chamber  71  is only half-open. In the use of the vacuum biopsy device, it is advisable to use a specially designed coaxial cannula that is tailored to the specifications and requirements of the device. The cannula must contain corresponding devices that prevent or preclude the entrance of air and the exit of tissue fluid; on the other hand, it should be able to be inserted easily into the tissue. The operation of the biopsy device is explained in detail below. 
         [0115]    The following segments of the procedure are performed extensively automatically after being initiated: a) starting and setting the initial position; b) clamping the biopsy needle and injecting it into the tissue; c) cutting the specimen out of the tissue (specimen collection); and d) removing the specimen after the closed biopsy needle has been removed from the tissue. 
         [0116]    a) Starting and Setting the Initial Position 
         [0117]    The removable insertion element  20 , comprising the vacuum- and pressure-generating device, the elastic connecting element and the biopsy-needle carrier with the needle and the blade sheath, and further elements connected thereto, and a guide roller  81  that is placed onto the needle are delivered in sterile packaging. The removable elements ( FIG. 2 ) are held by an insertion aid that is removed after the elements have been inserted into the hand piece. This insertion aid  104  has two grips for grasping the top, and brackets  108  for holding the biopsy-needle carrier  37  and the vacuum- and pressure-generating device. To secure the vacuum- and pressure-generating device in its position (parallel to the biopsy-needle carrier), a pin  110  provided on the bracket-holding device is inserted into the ventilation bore. 
         [0118]    The plunger  54  in the syringe body  52  is raised slightly (1 to 2 mm) from the bottom of the syringe, and the specimen-collection chamber  71  of the biopsy needle  2  is opened to allow visual checking of the specimen-collection chamber  71  prior to insertion. After the housing lid  10  has been opened, the biopsy-needle carrier, including the biopsy needle  2 , the cutting device  3  and other connected parts, such as the vacuum- and pressure-generating device  5  connected to the connecting element  4 , are inserted into the connecting elements provided on the hand piece ( FIG. 2 ). During the insertion process, it must be ensured that the gear  74  meshes with the teeth of the toothed roller  23 . The blade sheath is inserted from above into the U-shaped holding device  36 ; at the same time, the brackets  40  of the clamping carriage are guided into the recesses  77  of the carrier element, and the guide roller  81  is inserted into the passageway  13 , so it surrounds the flanks  101  and  102  of the housing end lid  6 . The blade sheath can be longitudinally displaced in the guide roller, and is seated to rotate freely; the guide roller itself, however, can no longer be displaced relative to the blade sheath following insertion into the housing end lid. 
         [0119]    On the one hand, the vacuum- and pressure-generating device is then inserted by the free end  61  into the insertion element  62  of the base block  8 , which is open to the top, and into the U-shaped passageway  16 , which is open to the top, by the connector  63 , on the other hand. The connector  63  lies above the switching pin  19 . Because the insertion element on the side of the base block has a clear width that just permits the insertion of the threaded spindle provided on both sides with surfaces  60 , the threaded spindle is held, fixed against relative rotation, in the insertion element. The gear rim  55  of the threaded-spindle nut  48  engages the drive pinion  56  of the gear motor after the insertion. The spacing between the base block and the housing end lid  7  is maintained to allow space for the syringe body  52  with the threaded-spindle nut  48  placed on the syringe body. The unit formed by the syringe body and the gear placed on it is held such that it cannot be axially displaced. 
         [0120]    After the insertion, the vacuum- and pressure-generating device lies parallel to the biopsy-needle carrier and the connecting element  4  describes a curve of about 180°. It should be noted that the insertion takes place when the clamping carriage is not clamped. This means that the gear  74  engages the right end of the toothed roller when the specimen-collection chamber  71  is open ( FIG. 3 ). After proper insertion, the housing lid can be closed. The described insertion aid can be employed to facilitate the insertion process. The insertion can also take place without the insertion aid, however. 
         [0121]    When the housing lid is closed, the connector  63  is pressed down, thereby actuating the microswitch by way of the switching pin  19  installed in the housing end lid. This activates the electrical system, which is indicated by the blinking reset diode (yellow)  91  on the front of the hand piece. The reset diode blinks yellow, which means that the positioning procedure for the individual elements, i.e., the insertion procedure, has not ended yet; the DC gear motor  21  must first close the specimen-collection chamber  71  with the blade sheath  3  (the specimen-collection chamber  71  was partially open during the insertion). This is effected by the rotation of the threaded sheath connected to the blade sheath. The blade sheath moves to the left until the gear  74  comes to rest near the inside of the holding device  36 . 
         [0122]    After the specimen-collection chamber  71  has been closed, the plastic disk  78  rests against the holding device  36  (inside). During this process, or before or after it, the DC gear motor  58  brings the syringe plunger  54  into contact with the bottom  51  of the syringe. In this phase, the counters of the microprocessor for the movement of the biopsy needle/blade sheath unit and the vacuum- and pressure-generating device are set at zero. From this initial position, the programmed movements are executed by way of the counting devices disposed on the two motors. After the initial positions for the vacuum- and pressure-generating device and the biopsy needle/blade sheath unit have been reached, the clamping diode  94  and the specimen-collection diode  92  illuminate (yellow and green, respectively), and the reset diode goes out. 
         [0123]    b) Clamping the Biopsy Needle and Injecting the Biopsy Needle into the Tissue 
         [0124]    In this phase, the operator must decide whether to initiate the clamping of the clamping carriage, or to collect a further tissue specimen after a first specimen has been collected, for example. When collecting a first tissue specimen, the operator depresses the clamping key  90 . This initiates the clamping of the clamping carriage; the clamping diode blinks yellow, and the specimen-collection diode (green)  92  goes out. The depression of the clamping key (because of the delay circuit, the key must be held down for about 1.2 to 1.5 seconds) effects the supply of current to the electrical DC gear motor  21 , which drives the toothed roller  23 . The gear  74  that meshes with the toothed roller  23  rotates the spindle shaft, and simultaneously the blade sheath  3  connected thereto. 
         [0125]    Because the spindle nut  75  is pressed into the biopsy-needle carrier  37 , and the gear  74  is supported against the holding device  36  by the plastic disk  78 , the holding device being permanently connected to the housing by the base block  8 , the rotation of the threaded-spindle sheath  73  causes the biopsy-needle carrier to move to the right. At the same time, the biopsy needle  2  connected to the biopsy-needle carrier via the bearing element  49  is carried along, which causes the tip of the biopsy needle to move into the blade sheath. The biopsy-needle carrier  37  is displaced to the right by way of the recess/bracket connection of the clamping carriage, and counter to the effect of the coil spring  31 , until the spring  34  presses the lever  33  of the latching element into the recess  82  of the clamping carriage. The clamping carriage is locked in this position. 
         [0126]    The gear motor receives the control command that the locked position has been reached, for example by way of a photocell that is recessed into the sliding surface of the cover plate and cooperates with the retracted biopsy-needle carrier, or by way of the microprocessor, which compares the actual rpm to the entered desired number, which was preprogrammed. The direction of rotation of the motor is reversed after the desired value has been attained, and the blade sheath is rotated back to the right by the distance that the blade sheath traveled past the biopsy-needle tip due to the displacement of the clamping carriage and the biopsy needle. At the end of this step, the blade sheath completely closes the specimen-collection chamber  71  ( FIG. 11 d   ), as at the beginning of the clamping process. The locking diode  95  illuminates green; the clamping diode  94  stops blinking. To reduce the frictional force between the gear and the support element during the clamping process, an additional plastic disk  78  is disposed between the gear  74  and the holding device  36 , for example. 
         [0127]    Now the biopsy needle of the biopsy device is inserted into a coaxial cannula that has been positioned in advance, for example. The proximal end of the positioned coaxial cannula has a seal that is dimensioned such that it seals the space between the blade sheath and the cannula, but permits the biopsy needle to be inserted easily with the blade sheath. The sealing ring prevents air from being sucked in from the outside via the space between the cannula and the blade sheath. Likewise, the sealing ring prevents the escape of fluid (cytological material) after the biopsy needle has been inserted or injected. Thus, it is virtually impossible to contaminate the disinfected hand piece, on the one hand; on the other hand, the flank  101  of the sterile guide roller  81  prevents the hand piece from becoming contaminated from the cannula. The tip of the biopsy needle is guided up to the swelling through the removal of the mandrel in the coaxial cannula and, after being positioned correctly, is injected into the swelling. 
         [0128]    The injection is initiated by the depression of the actuating key  88 . The depression of the key causes the clamping carriage to be released due to the pivoting of the two-armed lever  33  about the shaft  35 . The clamping carriage is thrown to the left by the spring action. The initiation of the injection and the new needle position are reported to the microprocessor, for example by an integrated photocell. The specimen-collection diode illuminates green, and the clamping diode illuminates yellow. 
         [0129]    c) Cutting the Sample Out of the Tissue 
         [0130]    A further depression of the programming key  89  initiates the specimen-collection procedure; the specimen-collection diode  92  blinks green. First, the DC gear motor  58  of the vacuum- and pressure-generating device is activated. The plunger of the vacuum- and pressure-generating device is moved in the direction of the base block, i.e., away from the bottom of the syringe, until it reaches a position shortly before the ventilation bore  67  is uncovered ( FIG. 14 b   ). The vacuum is generated in the system. After the end position has been attained, the system activates the motor  21 , and the gear/spindle drive opens the blade sheath, which seals the specimen-collection chamber  71 . During the opening process, the tissue and possible cytological fluid (cytological material) are supposed to be sucked or pressed into the specimen-collection chamber  71  due to the vacuum that dominates in the system, or an externally exerted pressure. Cytological fluid is sucked into the biopsy-needle hollow space through the vacuum, among other things, and flows into the vacuum- and pressure-generating device. 
         [0131]    It has proven advantageous that the stopper  79  diverts the vacuum primarily toward the lower region, the lower side, of the specimen-collection chamber  71 , and the stopper  79  impedes or prevents the penetration of tissue into the biopsy hollow needle. After the specimen-collection chamber  71  has been completely opened, or during the opening process, the biopsy needle is moved briefly back and forth about five times in a region of approximately 2 mm. In a preferred embodiment, the biopsy needle and thus the specimen-collection chamber  71  simultaneously perform an angular-rotational movement about the longitudinal axis. This movement is effected when the microprocessor issues the drive motor  21  the command to open the specimen-collection chamber  71  wider when the chamber is already completely open; this is impossible, because the collar  127  prevents a further displacement of the blade sheath to the right. 
         [0132]    The connection between the threaded spindle/threaded-spindle nut and the biopsy-needle carrier element causes the clamping carriage to be displaced to the distal side by about 2 mm, thereby compressing the short coil spring. After a predetermined rpm that corresponds to the distance of 2 mm has been attained, the microprocessor control system reverses the direction of rotation of the drive motor. The coil spring and the motor return the clamping carriage to its initial position. This action reverses the drive motor again, and the clamping carriage is again pulled counter to the effect of the short coil spring; after the clamping path has been traversed, the reversal is effected, and so on. Because of this back-and-forth movement, and the associated angular rotation of the biopsy needle, the tissue is severed by the longitudinal edges of the specimen-collection chamber  71 , and the specimen is reliably inserted into the specimen-collection chamber  71 , even if the tissue is tough. The procedure can be repeated an arbitrary number of times, depending on the programming. Generally, five cycles suffice to control the sharpened long sides of the specimen-collection chamber  71  to sever the lateral tissue of the tissue specimen, even if the tissue is hard or has inclusions, and to insert the specimen, easily and completely, into the specimen-collection chamber  71 , for example using a vacuum. 
         [0133]    It is emphasized here that, in the simplest case, the severing of the tissue can also be performed exclusively through the back-and-forth movement of the biopsy needle, especially if an external pressure is exerted, for example through ultrasound. The additional rotational movement about the needle&#39;s longitudinal axis can optionally be effected by the corresponding provision of the necessary measures explained above, and advantageously supports the tissue-severing process. 
         [0134]    Following the advantageous combined movement of the biopsy needle, as described above, the gear motor  21  is reversed and the specimen-collection chamber  71  is closed through the rotation of the blade sheath, with the cutting edge  72  of the blade sheath  3  severing the tissue during the closing process. Of course, a corresponding structural modification or a corresponding control and additional elements can also effect the back-and-forth movement or the angular-rotational movement of the biopsy needle for severing the lateral specimen edges, even as the blade sheath is opening. During the closing process, the blade sheath is advanced past its closed position by about 2 mm in the direction of the needle tip. This reliably severs the tissue fibers. Afterward, the blade sheath is retracted by 2 mm into the closed position. 
         [0135]    The microprocessor, in which the desired values are stored, effects the control of the processes; the microprocessor compares these data to the measured data (counting data), and controls the processes accordingly. The special configuration of the specimen-collection chamber  71 , and the possible generation of a vacuum, hold the tissue specimen in the specimen-collection chamber  71  without rotating, so the blade sheath  3  surrounding the outside of the biopsy needle and rotating as it is longitudinally displaced does not rotate or twist the tissue specimen, as described above. After the specimen-collection chamber  71  has been closed, the DC gear motor for the vacuum-pressure-generating device  5  is activated. First the plunger  54  is retracted until it uncovers the ventilation bore ( FIG. 11 c   ). After the vacuum in the system has been eliminated, the plunger advances toward the bottom of the syringe until the ventilation bore is closed again, in order to prevent bodily fluid (cytological fluid) from leaking out. This brief opening of the ventilation bore is in a range of fractions of a second to avoid the entry of fluid into the hand piece. To prevent fluid from entering the hand piece via the ventilation bore or bores for safety reasons, the bores can additionally be covered with air-permeable material, so the interior of the hand piece is not contaminated. The specimen-collection diode  92  stops blinking. The ejection diode  93  illuminates yellow. The biopsy needle with the closed collection chamber is pulled out of the cannula. 
         [0136]    d) Removing the Specimen after the Biopsy Needle has been Removed from the Tissue 
         [0137]    After the biopsy needle has been removed from the tissue and a container has been prepared for receiving the tissue specimen and the tissue fluid, the programming key  89  is depressed again and the ejection diode  93  begins to blink. For safety reasons, the delay circuit stipulates that the programming key must be depressed for about 1.2 to 1.5 seconds before the procedure is initiated. First, the gear motor  21  of the blade sheath is actuated in order to open the specimen-collection chamber  71  about halfway. Afterward, the DC gear motor  58  of the vacuum- and pressure-generating device is activated. The direction of rotation of the DC gear motor  58  is maintained, and the threaded spindle  53  moves, with the plunger, in the direction of the bottom of the syringe, so an overpressure now exists in the system. The plunger  54  is advanced toward the bottom of the syringe  52  and the drive motor  58  is deactivated. The gear motor  21  retracts the blade sheath further over the specimen-collection chamber  71  once the plunger has reached the bottom of the syringe  52 . 
         [0138]    Because of the overpressure that has built up in the system, the specimen is pushed out under pressure into a prepared laboratory container when the specimen-collection container is only half-open. At the same time, the hollow space of the vacuum- and pressure-generating device, the biopsy needle and the specimen-collection chamber  71  is cleared of tissue particles and fluid. The specimen is ejected when the specimen-collection chamber  71  is about half-open because this assures the ejection of the tissue specimen—it does not fall back into the specimen-collection chamber  71  due to a premature loss of the overpressure. The narrowing of the biopsy-needle hollow space by the stopper  79 , which impedes or prevents the entrance of tissue into the biopsy-needle hollow space, has proven especially advantageous in specimen collection, because the narrowed cross-section increases the ejection pressure. The best ejection results were obtained with a half-open specimen-collection chamber  71 , that is, when the blade sheath exposed half of the axial length of the specimen-collection chamber  71 . The overpressure also pushes tissue fluid out of the specimen-collection chamber  71 , and cleans it. 
         [0139]    After the specimen-collection chamber  71  has been completely opened, and the removal and cleaning have been performed, the ejection diode goes out. The reset diode  91  illuminates yellow. Provided that no further specimens are to be collected, the housing lid is opened and the removable element  20  is removed. When the housing lid  10  is opened, the microswitch  18  deactivates the system. If, however, a further specimen is to be collected from the same area of tissue, the operator depresses the programming key  89 , and the reset diode  91  begins to blink. The vacuum- and pressure-generating device  5 , as well as the blade sheath, returns to the initial position. 
         [0140]    After the procedure has been completed, the reset diode  91  goes out and the specimen-collection diode and the clamping diode illuminate (green and yellow, respectively). Now the operator must decide whether he wants to collect only one further tissue specimen from the same injection site, in which case he depresses the programming key  89 , or wants to create a new injection site by clamping the biopsy needle, in which case he depresses the clamping key  90 . Depending on his selection, the further process steps are performed in the order described above. The procedure can be repeated as many times as desired. After the specimen has been ejected, the operator need only decide whether he wants to collect a further specimen, or end the specimen collection and open the housing lid. 
         [0141]    If it is necessary to collect the specimen at a site of the swelling that is not located directly above or at the specimen-collection chamber  71  following the injection—for example, it is located to the side—the knurled knob  80  can be used to rotate the position of the specimen-collection chamber  71 . To allow the operator to verify the radial position of the specimen-collection chamber  71 , the knurled knob is provided with a marking in the form of a notch  119 , which faces up when the opening of the specimen-collection chamber  71  faces up. In the respectively set position, the biopsy needle is fixed in place by the surfaces of the polygonal member  50  and the elastic forces in the carrier part. The specimen-collection procedure is the same as described above. 
         [0142]    After the biopsy has been completed, the lid is unlatched and the replaceable element  20  (vacuum- and pressure-generating device, biopsy needle/blade device with all elements attached thereto) is lifted up and out. To make it impossible to open the housing when the clamping carriage is clamped, a fastening panel  84  is disposed on the biopsy-needle carrier. In the clamped state, the panel rests against the left end face  85  of the closing device. The closing device, which can be displaced in the X-axis, can no longer be moved to the left into the open position, and therefore the latch  12  can no longer be removed from the recess  45 . Conversely, the housing lid cannot be closed if the removable element has been inserted into the pre-clamped clamping carriage, because the fastening panel prevents the bar from being inserted into the space provided for it. The surface  85  of the bar impacts the fastening panel. The battery-charging diode  96  is shut off as soon as the housing lid is opened. When the lid is closed and the insertion element  20  is inserted, the battery-charging diode indicates whether enough power is available. 
         [0143]    In principle, it is conceivable to control all of the steps for collecting a specimen and clamping the carriage, etc., by manually activating and deactivating the two gear motors individually. It is advantageous, however, to combine individual steps of the procedure and perform them automatically, so only the initiation of the sequence is effected by the actuation of a switch. As described above, this semi-automatic method has proven especially advantageous. 
         [0144]    In principle, there are two conceivable methods for ascertaining the actual values for the comparison with the desired values. One method is based on measuring the longitudinal displacement of the threaded spindle during insertion or withdrawal, and measuring the axial displacement of the blade sheath or the biopsy-needle carrier. Photocells or microswitches are provided inside the housing, particularly on the extension of the base block  8 , for detecting these changes. A positioning finger  103  is additionally provided on the blade sheath for photocell measurement of the changes, while the free end  61  of the threaded spindle of the vacuum- and pressure-generating device, the end protruding from the plunger unit, can be used as a measurement point. In the use of the front edge of the biopsy-needle carrier as a measurement point with a photocell, there is no need for an additional positioning finger. The recessed photocells are covered with a suitable transparent material to prevent possible contamination. The positioning finger  103  extends through a slot in the biopsy-needle holder. Recesses  107  are provided at corresponding locations on the extension  46  of the base block  8 . Photocells or microswitches are installed into these recesses, and cooperate with the free end  61  of the plunger spindle, with the positioning finger, or the edge  120  of the biopsy-needle carrier ( FIG. 15 ). These signals (actual values) are processed in the electronic components, and form the control signals. 
         [0145]    The other system is based on measuring the rpm of the DC gear motors, which are converted into units of length; this is particularly advantageous when the gear motors effect the changes. In this instance, a detector is mounted to the shaft of the DC motor, and cooperates with a photocell mounted to the housing of the DC motor. This detector comprises a two-armed blade wheel  131  and a photocell that is connected to the motor ( FIG. 3 ). These detectors on the two drive motors supply the counting pulses for the photocells, which transmit them further to the programmable microprocessor, which compares these ascertained data to the stored specifications and triggers the control pulses accordingly. Because the DC motors operate with an rpm of about 10,000 to 12,000, as a function of load, and the downstream planetary gear that is disposed on the power takeoff side and cooperates with the spindle drive significantly reduces the rpm, this permits a precise longitudinal control. The longitudinal displacement by the spindle drives is a consistently identical amount, proportional to the number of drive revolutions, and the number of revolutions is therefore sufficient as a control signal for the precision of the longitudinal displacement. For precisely determining the position of the blade sheath  3  and the plunger  54  at the beginning, that is, after the removable element has been inserted and the housing lid  10  has been closed, the DC gear motor  58  rotates the plunger  54  until it stops against the bottom of the syringe, and the DC gear motor  21  brings the blade-sheath drive to the zero position by bringing the gear  74  to a stop against the threaded-spindle nut  75  (the threaded-spindle nut  75  runs onto the gear  74 ). From this zero position, the individual steps are then controlled by comparing the settings and actual values. The necessary cables from the measurement detector to the electronic components are accommodated in the housing, as is the plate with the electronic components. If necessary, it is also possible to combine the two described control systems. 
         [0000]    
       
         
               
             
               
               
             
           
               
                   
               
               
                 Parts List 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 1 
                 Handpiece 
               
               
                 2 
                 Biopsy needle 
               
               
                 3 
                 Blade sheath 
               
               
                 4 
                 Connecting element 
               
               
                 5 
                 Vacuum pressure-generating 
               
               
                   
                 device 
               
               
                 6 
                 Housing end lid (left) 
               
               
                 7 
                 Housing end lid (right) 
               
               
                 8 
                 Base block 
               
               
                 9 
                 Lower housing part 
               
               
                 10 
                 Housing lid 
               
               
                 11 
                 Locking bar 
               
               
                 12 
                 Latch 
               
               
                 13 
                 Passageway 
               
               
                 14 
                 Bore 
               
               
                 15 
                 Passageway 
               
               
                 16 
                 Passageway 
               
               
                 17 
                 Tappet 
               
               
                 18 
                 Microswitch 
               
               
                 19 
                 Switching pin 
               
               
                 20 
                 Removable element 
               
               
                 21 
                 DC gear motor 
               
               
                 22 
                 Wall 
               
               
                 23 
                 Toothed roller 
               
               
                 24 
                 U-shaped space 
               
               
                 25 
                 Wall 26 Block 
               
               
                 27 
                 Groove 
               
               
                 28 
                 Clamping carriage 
               
               
                 29 
                 Threaded bore 
               
               
                 30 
                 Pin 
               
               
                 31 
                 Coil spring 
               
               
                 32 
                 End piece 
               
               
                 33 
                 Articulated lever 
               
               
                 34 
                 Compression spring 
               
               
                 35 
                 Shaft 
               
               
                 36 
                 Holding device 
               
               
                 37 
                 Biopsy-needle carrier 
               
               
                 38 
                 Bores 
               
               
                 39 
                 Legs 
               
               
                 40 
                 Brackets 
               
               
                 41 
                 Surface of clamping carriage 
               
               
                 42 
                 Surface extension 
               
               
                 43 
                 Sliding surface 
               
               
                 44 
                 Surface of block 26 
               
               
                 45 
                 Recess 
               
               
                 46 
                 Cover 
               
               
                 47 
                 Plastic part 
               
               
                 48 
                 Threaded-spindle nut 
               
               
                 49 
                 Bearing element 
               
               
                 50 
                 Polygonal member 
               
               
                 51 
                 Bottom of syringe 
               
               
                 52 
                 Syringe body 
               
               
                 53 
                 Threaded spindle 
               
               
                 54 
                 Plunger 
               
               
                 55 
                 Gear (Gear rim) 
               
               
                 56 
                 Drive pinion 
               
               
                 57 
                 Operating panel 
               
               
                 58 
                 DC gear motor 
               
               
                 59 
                 Transverse plate 
               
               
                 60 
                 Surfaces 
               
               
                 61 
                 Free end 
               
               
                 62 
                 Insertion element 
               
               
                 63 
                 Connector 
               
               
                 64 
                 Discharge connector 
               
               
                 65 
                 Recess 
               
               
                 66 
                 Phase 
               
               
                 67 
                 Ventilation bore 
               
               
                 68 
                 Blade (longitudinal edges) 
               
               
                 69 
                 Plunger/cylinder unit 
               
               
                 70 
                 Needle tip 
               
               
                 71 
                 Specimen-collection chamber 
               
               
                 72 
                 Blade 
               
               
                 73 
                 Threaded-spindle sheath 
               
               
                 74 
                 Gear 
               
               
                 75 
                 Threaded-spindle nut 
               
               
                 76 
                 Sealing element 
               
               
                 77 
                 Recesses 
               
               
                 78 
                 Plastic disk 
               
               
                 79 
                 Stopper 
               
               
                 80 
                 Knurled knob 
               
               
                 81 
                 Guide roller 
               
               
                 82 
                 Recess 
               
               
                 83 
                 Metal component 
               
               
                 84 
                 Fastening panel 
               
               
                 85 
                 End face 
               
               
                 86 
               
               
                 87 
                 Center rib 
               
               
                 88 
                 Actuating key 
               
               
                 89 
                 Programming key 
               
               
                 90 
                 Clamping key 
               
               
                 91 
                 Reset diode 
               
               
                 92 
                 Specimen-collection diode 
               
               
                 93 
                 Ejection diode 
               
               
                 94 
                 Clamping diode 
               
               
                 95 
                 Locking diode 
               
               
                 96 
                 Battery-charging diode 
               
               
                 97 
                 Passageway 
               
               
                 98 
                 Passageway 
               
               
                 99 
                 Arm of two-armed lever 
               
               
                 100 
                 Part of lever 
               
               
                 101 
                 Flank of guide roller - left 
               
               
                 102 
                 Flank of guide roller - right 
               
               
                 103 
                 Positioning finger 
               
               
                 104 
                 Shaft 
               
               
                 105 
                 Drive device (vacuum) 
               
               
                 106 
                 Drive device (biopsy needle, 
               
               
                   
                 clamping device) 
               
               
                 107 
                 Recesses 
               
               
                 108 
                 Brackets 
               
               
                 109 
                 Insertion aid 
               
               
                 110 
                 Pin 
               
               
                 111 
                 Accumulator battery 
               
               
                 112 
                 Plastic part 
               
               
                 113 
                 Surface 
               
               
                 114 
                 Separating plate 
               
               
                 115 
                 Guide bore 
               
               
                 116 
                 Cap element 
               
               
                 117 
                 Holding pieces 
               
               
                 118 
                 N.N. 
               
               
                 119 
                 Notch 
               
               
                 120 
                 N.N. 
               
               
                 121 
                 Disk insert 
               
               
                 122 
                 Lip 
               
               
                 123 
                 Collar 
               
               
                 124 
                 Short coil spring 
               
               
                 125 
                 Disk insert 
               
               
                 126 
                 Tubular part 
               
               
                 127 
                 Collar 
               
               
                 128 
                 Distal bore in carriage 
               
               
                 129 
                 Proximal-side bore in block 26 
               
               
                 130 
                 Photocell 
               
               
                 131 
                 Blade wheel 
               
               
                 139 
                 Space 
               
               
                 O 
                 Deformed point 
               
               
                 S 
                 Inscribed circle diameter 
               
               
                 A 
                 Clear spacing 
               
               
                 X 
                 Proximal displacement 
               
               
                 X 
                 Distal displacement 
               
               
                   
                 Rotational angle - right 
               
               
                   
                 Rotational angle - left 
               
               
                 H 
                 Height of specimen-collection 
               
               
                 F 
                 Height of opening 
               
               
                 T 1   
                 Partial piece 
               
               
                 ra 
                 Outside diameter 
               
               
                 ri 
                 Inside diameter