Biopsy device
A manually operated biopsy device with a rotating biopsy blade addresses the challenges of obtaining high-quality tissue samples by employing precise rotational and translational movements, enhancing the quality and safety of tissue acquisition.
Patent Information
- Application Number
- PCT/EP2023/084176
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-12-04
- Publication Date
- 2025-06-12
AI Technical Summary
Current biopsy devices, particularly those used in ultrasound endoscopes, face challenges in obtaining high-quality tissue samples due to imprecise methods and associated risks, especially with punch biopsies over longer paths.
A manually operated biopsy device without electrical drives, utilizing a rotating biopsy blade for cutting, which allows for precise tissue sampling by translating the biopsy cutting head in both rotational and translational movements.
The device effectively obtains high-quality tissue samples suitable for pathological and genetic examinations, reducing the risks associated with existing methods by employing a cutting method that ensures precise and controlled tissue acquisition.
Smart Images

Figure EP2023084176_12062025_PF_FP_ABST
Abstract
Description
[0001] BIOPSY DEVICE
[0002] Description
[0003] The present disclosure relates to a biopsy device, in particular a manually operated biopsy device without electrical drives, preferably for use in ultrasound endoscopes.
[0004] background
[0005] Biopsies are used to obtain small tissue samples (sometimes just a few millimeters in size) from a living human or animal body. The removed tissue (also called a biopsy specimen) can then be examined by a specialist (e.g., a pathologist), particularly for histological examination of the removed tissue under a microscope or, for example, through chemical or genetic analyses for the diagnosis of specific diseases.
[0006] In particular, stripping, suction, cutting, or punching techniques are used to obtain tissue, whereby the quality of the extracted tissue is strongly influenced by the method chosen. For example, puncture techniques (sometimes using negative pressure to "suck in" the punched tissue sample(s)) cannot obtain tissue samples of sufficient quality suitable for further pathological or genetic examinations. Furthermore, punch biopsies over a longer path in ultrasound endoscopes, as is the case with EUS or EBUS endoscopes, for example, are imprecise and associated with risks. Furthermore, the quality of the extracted tissue samples for histological examinations with the biopsy devices currently available indicates a need for optimization.
[0007] To address this issue, the present invention proposes to use a cutting method for sampling, which obtains the biopsy specimen by means of a rotating biopsy blade.
[0008] In view of the disadvantages described above, it is an object of the present application to provide a biopsy device, in particular a manually operated biopsy device without electrical drives, which eliminates the aforementioned disadvantages.
[0009] Summary
[0010] The present disclosure relates to a biopsy device, in particular a manually operated biopsy device without electrical drives.
[0011] In particular, to achieve the above-mentioned object, a biopsy device according to claim 1 is proposed. The dependent claims relate to some exemplary preferred embodiments.
[0012] According to an exemplary aspect, a biopsy device is proposed, comprising: a transfer element which is rotatably movable by an external force and translationally movable due to the rotation, wherein the transfer element is translationally movable in a first translation direction upon rotation in a first rotational direction, and is translationally movable in a second translational direction opposite to the first rotational direction upon rotation in a second rotational direction opposite to the first translational direction, a biopsy cutting head which is configured to receive a tissue sample, and a coupling section which is arranged between the biopsy cutting head and the transfer element and is configured toto transfer the rotation of the transfer element in the first rotation direction and the translation of the transfer element in the first translation direction for a first partial movement of the biopsy cutting head to the biopsy cutting head.
[0013] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the coupling section is further configured to transmit the translation of the conversion element in the second translation direction for a second partial movement of the biopsy cutting head to the biopsy cutting head and to decouple the rotation of the conversion element in the second rotation direction from the biopsy cutting head.
[0014] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the first partial movement of the biopsy cutting head is a rotary forward movement of the biopsy cutting head into the tissue to be biopsied in order to pick up a part of the tissue to be biopsied, and the second partial movement of the biopsy cutting head is a backward movement of the biopsy cutting head with the picked up part of the tissue to be biopsied out of the tissue.
[0015] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the biopsy device is further configured to carry out the recording of a part of the tissue to be biopsied essentially under an ambient pressure of the biopsy device within the biopsy cutting head.
[0016] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the coupling section has a connecting element that is effectively connected to the biopsy cutting head, and a coupling element that is arranged between the connecting element and the conversion element and is effectively connected to the conversion element, wherein the connecting element and the coupling element are configured to come into contact with one another upon rotation of the conversion element in the first rotational direction and thereby to transmit the rotation of the conversion element to the connecting element via the coupling element, and to release the contact with one another upon rotation of the conversion element in the second rotational direction and thereby to decouple the rotation of the conversion element from the connecting element.
[0017] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that when the connecting element comes into contact with the coupling element, both elements engage with each other, wherein the connecting element and the coupling element each have at least one engagement section for this purpose.
[0018] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the at least one engagement portion of the coupling element is formed on the side of the coupling element that faces the connecting element, and the at least one engagement portion of the connecting element is formed on the side of the connecting element that faces the coupling element.
[0019] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the respective at least one engagement section of the connecting element and the coupling element is substantially tooth-shaped or wedge-shaped, and wherein the tooth or wedge shape is configured to transmit the rotation in the first rotational direction of the conversion element from the coupling element to the connecting element.
[0020] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the coupling section has a transmission element in which the connecting element and the coupling element are received, wherein the transmission element is designed to transmit the translation of the conversion element to the connecting element via the coupling element upon rotation of the conversion element in the second rotation direction.
[0021] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the connecting element is received in the transmission element exclusively in a rotatable manner and the coupling element is received in the transmission element in a rotatable and translationally movable manner.
[0022] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the transmission element is translationally movable within the biopsy device and secured against rotation.
[0023] According to particularly expedient embodiments, the biopsy device can be advantageously further developed by a force introduction element which is rotatable in the first and second rotation directions by introducing an external force and is designed to transmit the rotation to the conversion element.
[0024] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the external force is a force introduced by hand of a user of the biopsy device for rotating the force introduction element.
[0025] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the conversion element has a first section with a thread that engages with an element fixed within the biopsy device in order to convert the rotation of the conversion element into the translation of the conversion element, which translation overlays the rotation. According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the conversion element has a second section that interacts with the force introduction element in such a way that the rotation of the force introduction element is transmitted to the conversion element, wherein the force introduction element is decoupled from the translation of the conversion element.
[0026] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the biopsy device is further configured such that the connecting element, the coupling element, the conversion element and the force introduction element rotate at the same angular velocity when rotating in the first direction of rotation, and the coupling element, the conversion element and the force introduction element rotate at the same angular velocity when rotating in the second direction of rotation.
[0027] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the biopsy device is further configured such that the connecting element, the coupling element, the conversion element and the force introduction element rotate in the same direction of rotation when rotating in the first direction of rotation, and the coupling element, the conversion element and the force introduction element rotate in the same direction of rotation when rotating in the second direction of rotation.
[0028] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the biopsy cutting head is designed as a hollow cylinder and has at least one cutting section with a cutting edge at one end facing the tissue to be biopsied, wherein the at least one cutting section is substantially wedge-shaped and has a cylindrical outer side common to the biopsy cutting head, and wherein the cutting edge extends parallel to a rotation axis of the biopsy cutting head or at an angle to a longitudinal axis of the biopsy cutting head lying in a lateral surface of the hollow cylinder.
[0029] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the angle is configured in a range of 1° - 10°, preferably in the range of 3° - 8°, and particularly preferably in the range of 5° - 6°. According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the cutting edge has a single-sided grind.
[0030] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the one-sided grinding of the cutting edge faces an inner side of the cutting section of the biopsy cutting head and an outer contour of the cutting edge essentially corresponds to the outer side of the cutting section, in particular of the biopsy cutting head.
[0031] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the at least one cutting section is designed to taper distally at an angle of 15° to 30°, preferably at an angle of 20° to 25°, and particularly preferably at an angle of 22.5°.
[0032] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the biopsy cutting head has two cutting sections which are rotationally symmetrical on the biopsy cutting head.
[0033] According to particularly expedient embodiments, the biopsy device can be advantageously further developed by a stylet which is arranged within the biopsy cutting head and is configured to be retracted into a first position for the first partial movement of the biopsy cutting head in order to enable the biopsy cutting head to pick up a part of the tissue to be biopsied, and to be advanced into a second position in order to press the picked up part of the tissue to be biopsied out of the biopsy cutting head.
[0034] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that a force introduction element of the biopsy device, by means of which the external force is transmitted to the transfer element, has a receptacle for a stylet operating element which is effectively connected to the stylet, and wherein the force introduction element has at least two locking points for locking the stylet operating element for positioning the stylet in the first and second positions.
[0035] According to particularly expedient embodiments, the biopsy device can be advantageously further developed by at least one telescopically adjustable device section, which is designed to adapt the biopsy device to a length of an endoscope or to position the biopsy cutting head of the biopsy device to the tissue to be biopsied, and a locking section, which is designed to lock the at least one telescopically adjustable device section to the respective adaptation of the biopsy device, wherein the locking section has a rotatably mounted clamping section, which is designed to generate the locking of the at least one telescopically adjustable device section by a rotating change in position relative to the locking section.
[0036] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the clamping section generates a clamping and / or friction force for locking the at least one telescopically adjustable device section by rotating the position change relative to the locking section.
[0037] According to particularly expedient embodiments, the biopsy device can be advantageously further developed in that the rotatably mounted clamping section is designed as an elliptical clamping section.
[0038] Further aspects and their advantages as well as advantages and more specific embodiments of the aspects and features described above are described in the following, but in no way limiting, descriptions and explanations of the attached figures.
[0039] Short description of the characters
[0040] Fig. 1 shows an exemplary representation of an embodiment of a biopsy device in a plan view with the different areas of the exemplary biopsy device,
[0041] Fig. 2 shows an exemplary representation of the embodiment of the biopsy device according to Fig. 1 in a sectional view with visible biopsy mechanism,
[0042] Fig. 3 shows an exemplary representation of an embodiment of the biopsy mechanism in a sectional view,
[0043] Fig. 4 shows a further exemplary representation of an embodiment of the biopsy mechanism in a sectional view, Fig. 5 shows a further exemplary representation of an embodiment of the biopsy mechanism in a sectional view with further details of the coupling section,
[0044] Fig. 6 shows a further exemplary representation of an embodiment of the coupling section with the connecting element and the coupling element,
[0045] Fig. 7 shows an exemplary representation of an embodiment of the telescopically adjustable device section,
[0046] Fig. 8 shows an exemplary representation of an embodiment of the stylet control element,
[0047] Fig. 9 shows an exemplary representation of an embodiment of a mounting section of the biopsy device for exemplary mounting on an endoscope,
[0048] Fig. 10a shows an exemplary representation of an embodiment of a
[0049] Biopsy blade with appropriate cutting geometries,
[0050] Fig. 10b shows exemplary representations of further biopsy cuts with
[0051] Cutting edge geometries.
[0052] Detailed description of the figures and preferred embodiments
[0053] Examples and embodiments of the present disclosure are described in detail below with reference to the accompanying figures. Identical or similar elements in the figures may be designated by the same reference numerals, but sometimes also by different reference numerals.
[0054] It should be emphasized, however, that the subject matter of the present disclosure is in no way limited or restricted to the exemplary embodiments and their design features described below, but rather further encompasses modifications of the exemplary embodiments, in particular those encompassed by modifications of the features of the described examples or by combining one or more of the features of the described examples within the scope of the independent claims. Fig. 1 shows an exemplary representation of an exemplary embodiment of a biopsy device 1000 in a plan view with the various regions 200-900 as well as the biopsy blade 50 and the stylet 20 of the exemplary biopsy device 1000.
[0055] In this case, for example, the biopsy device 1000 can have a handle section 800, by means of which the exemplary biopsy device 1000 can be held by a corresponding user (for example, by a corresponding specialist). In addition, a position indicator section 900 with a corresponding scale can be provided, for example, on the side of the handle section 800 of the biopsy device 1000. This allows the user to keep an eye on the position of the biopsy cutter 50 relative to the biopsy device 1000 during tissue removal after the biopsy cutter 50 has been positioned on the tissue to be biopsied. For example, the user can thus read how far the biopsy cutter 50 (and in particular the biopsy cutter head 51; not shown here, see Figs. 10a, 10b) has already penetrated into the tissue to be biopsied.how much tissue (quantitatively) was taken up by the corresponding forward movement V of the biopsy blade 50 and, during the backward movement R of the biopsy blade 50, whether the biopsy blade 50 has, for example, been completely withdrawn from the tissue to be biopsied.
[0056] In addition, as is also described in Fig. 4, the forward movement V of the biopsy blade 50 can in particular be a superimposed rotational and translational movement (rotating forward movement), wherein during the rotational movement the biopsy blade 50 rotates in the direction in which the blades 51a of the biopsy cutting head 51 (see also Figs. 10a, 10b) cut the tissue to be biopsied, and during the simultaneous translational movement, which is dependent on the rotational movement, the biopsy blade 50 is advanced further / deeper into the tissue to be biopsied.
[0057] In contrast, during the backward movement R of the biopsy cutting edge 50, only a translational movement of the biopsy cutting edge 50 is carried out, since this allows the removal of the tissue sample to take place more safely, since no additional rotational movement takes place when moving the biopsy cutting head 51 out of the tissue to be biopsied.
[0058] For the described forward and backward movements V, R, the biopsy device 1000 can, for example, have a force introduction section of a force introduction element 200, by means of which the user can control the forward and backward movement V, R of the biopsy blade 50. As shown here by way of example, this can be effected by a rotation of the force introduction element 200, for example, when viewed from the force introduction element 200 in the direction of the
[0059] Biopsy cutting head 51 of the biopsy blade 50, with a rotation of the
[0060] Force introduction element 200 to the right (here also shown as V) the
[0061] Forward movement V of the biopsy blade 50 and with a rotation of the force introduction element 200 to the left (here also shown as R) the
[0062] Backward movement R of the biopsy blade 50.
[0063] Furthermore, the exemplary biopsy device 1000 can have a stylet operating element 300. The stylet 20 is an element that extends within the biopsy cutting edge 50, which, as shown here, is embodied as a tubular / hollow-cylindrical element, and can either expose the inner section of the biopsy cutting head 51 for the reception of tissue (by appropriately retracting the stylet 20 within the biopsy cutting edge 50) or, when the stylet 20 is advanced in the biopsy cutting edge 50 up to the cutting edges of the biopsy cutting head 51, can correspondingly close the inner section of the biopsy cutting head 51. Furthermore, the received tissue can be pushed out of the inner section of the biopsy cutting head 51 again by advancing the stylet 20.For this forward and backward movement of the stylet 20 within the biopsy blade 50, the stylet control element 300 can be used, for example, whereby reference is made to the explanations for Fig. 8 for further details.
[0064] In addition, the exemplary biopsy device 1000 can have telescopically adjustable device sections 540, 440 (not shown here, see Fig. 7 for this), which can be locked in their respective adjusted lengths by corresponding locking sections 400, 500. For example, the locking section 400 can be configured for adjusting and locking the adaptation of the exemplary biopsy device 1000 to a length of the endoscope to be used for the biopsy, and the locking section 500 can be configured, for example, for advancing the biopsy cutting head 51 of the biopsy device 1000 toward the tissue to be biopsied and locking this position; further reference is made to the descriptions for Fig. 7 for this purpose.
[0065] Furthermore, the exemplary biopsy device 1000 may have a mounting portion 600 for connection to a corresponding endoscope, which is shown and described in more detail in Fig. 9. Fig. 2 shows an exemplary representation of the embodiment of the biopsy device 1000 according to Fig. 1 in a sectional view with visible biopsy mechanism 100 and coupling portion 150.
[0066] By way of example, it is shown that the biopsy mechanism 100 can have a section for implementing the rotational movement of the force introduction element 200, which can have a force introduction section 210, as well as a coupling section 150 for transmitting and / or decoupling the rotational movement of the force introduction element 200 / force introduction section 210 from the biopsy blade 50.
[0067] For further details on converting the rotational movement of the force introduction element 200 / force introduction section 210 into, for example, another form of movement and / or an additional form of movement, reference is made to the explanations for Fig. 3.
[0068] In addition, for further details on transmitting and / or uncoupling the rotational movement of the force introduction element 200 / force introduction section 210 from the biopsy blade 50, reference is made to the explanations for Figs. 4 and 6.
[0069] Furthermore, it can be seen by way of example that the stylet 20 extends essentially completely through the entire exemplary biopsy device 1000, starting at the stylet operating element 300, which may have an operating section 310, up to the biopsy cutting head 51 of the biopsy blade 50 (and partially even beyond, as shown). However, this design can be advantageous because the stylet 20, as shown here by way of example, can be inserted into the inner section of the biopsy blade 50 in the region of the coupling section 150 and from there guided through the biopsy blade 50 to the biopsy cutting head 51.
[0070] The biopsy cutter 50, in turn, can extend substantially from the coupling portion 150 toward the mounting portion 600 of the exemplary biopsy device 1000 (distal end of the biopsy device 1000) and have the biopsy cutter head 51 at an end of the biopsy cutter 50 (distal end of the biopsy cutter 50) opposite the coupling portion 150.
[0071] Furthermore, as shown here by way of example and can be seen in detail in Fig. 7, a tubular guide element 560 (not explicitly numbered here, see Fig. 7) can extend from one end of the telescopically adjustable device section 540 (also not explicitly numbered here, see Fig. 7), which is configured, for example, to advance the biopsy cutting head 51 of the biopsy device 1000 towards the tissue to be biopsied, to the mounting section 600 and beyond.
[0072] Fig. 3 shows an exemplary representation of an embodiment of the biopsy mechanism 100, in particular the section of the conversion of the rotational movement of the force introduction element 200 / force introduction section 210 into, for example, another form of movement and / or an additional form of movement, in a sectional view.
[0073] For this purpose, the force introduction element 200 firstly has the force introduction section 210, which can have a corresponding structure / shape on its outer surface for introducing an external force, for example, a rotational force applied manually by the user. The outer surface can, for example, on the one hand, allow optimal force introduction by the user's hand into the force introduction element 200 due to its structure / shape and, on the other hand, for example through the structuring of the surface of the force introduction section 210, which can, for example, be formed in sections along the circumference of the force introduction element 200, provide the user with haptic feedback about the rotation / turn and, at least partially and / or at least roughly, about the angle of rotation.
[0074] In addition to the force introduction section 210, the force introduction element 200 can further comprise a force transmission section 220, which is configured to transmit the introduced rotational movement / rotational force from the force introduction section 210 to the conversion element 110. For this purpose, the force transmission section 220 can, for example, extend elongatedly, in sections tubularly, from the force introduction section 210 parallel to the stylet 20 or in the direction of the distal end of the exemplary biopsy device 1000 and, on its outer surface, further comprise at least one recess 221 extending in the longitudinal direction of the force transmission section 220 (see Fig. 8), which engages with a section 111 protruding inward into the tubular section of the conversion element 110.
[0075] This protruding portion 111 of the transfer element 110 is configured and engaged with the recess 221 of the force introduction element 200 such that a rotational force / rotation of the force introduction element 200 can be transmitted to the transfer element 110, while still allowing the transfer element 110 to move along the longitudinal direction of the force transmission portion 220 (axial direction of the biopsy device 1000) relative to the force introduction element 200. For this purpose, the cross-sectional shape of the protruding portion 111 of the transfer element 110 can, for example, have the shape of a roof edge / triangle or that of a trapezoid or a partial circle (or another shape) and extend constantly in the axial direction of the biopsy device 1000 along the inside of the tubular portion of the transfer element 110.The shape (cross-sectional shape) of the recess 221 of the force transmission section 220 as a counterpart engaged with the protruding section 111 would be corresponding and would also extend in the axial direction of the biopsy device 1000 or in the longitudinal direction of the force transmission section 220.
[0076] This mobility of the transfer element 110 in the axial direction of the biopsy device 1000 relative to the force introduction element 200 is advantageous in that when this rotation / rotational movement of the transfer element 110 is converted into a translational movement in the axial direction of the biopsy device 1000 (as a different or additional movement), this movement is decoupled from the force introduction element 200 and the position of the force introduction element 200 in the axial direction of the biopsy device 1000 relative to the biopsy device 1000 always remains constant, even during a rotating movement of the force introduction element 200.
[0077] In addition, the force transmission section 220 can have a through opening 222 (see Fig. 8) extending substantially centrally in the axial direction of the biopsy device 1000, within which the stylet 20 can be provided and which is designed such that it can receive a stylet receiving section 320 (see Fig. 8 here too) of the stylet operating element 300.
[0078] The transfer element 110 can further comprise a transfer section 112 which is in engagement with a corresponding counter element 120 which is fixed in position and position within the biopsy device 1000 and which, together with the counter element 120, converts the rotation / rotational movement of the transfer element 110 into a combination / superposition of rotational and translational movement of the transfer element 110 (see the rotation arrow with V and R and the translational arrow with V and R), wherein the translational movement of the transfer element 110 is dependent on the rotational movement of the transfer element 110.For this purpose, thread-shaped sections of the conversion section 112 and the counter element 120 can be suitable, for example, or simply at least one correspondingly (helically) shaped groove, for example on the conversion section 112 of the conversion element 110, and a protruding section (for example a protruding pin) of the counter element 120, with which the groove of the conversion element 110 is in engagement.
[0079] It may also be advantageous to provide a defined pitch (path length of the translational movement per full revolution) of the thread-shaped sections or of the at least one helical groove for the removal of tissue during the actual biopsy, in which the biopsy blade 50 is moved into the tissue to be biopsied by means of this movement conversion, for example a pitch in the range of 5 - 20 mm, in particular in the range of 8 - 15 mm, and in particular of 10 mm.
[0080] As a result, the user can achieve a relatively large advance of the biopsy cutter 50 / biopsy cutter head 51 into the tissue to be biopsied with comparatively few revolutions of the force introduction element 200, which are transferred one-to-one to the conversion element 110 (forward movement V: Vrot of the force introduction element 200 is equal to Vrot of the conversion element 110; backward movement R: Rrot of the force introduction element 200 is equal to Rrot of the conversion element 110). This also makes it possible to collect or remove a comparatively large amount of tissue to be examined with a single removal movement (a forward movement V and a backward movement R of the biopsy cutter 50) after the biopsy device 1000 orthe biopsy cutting head 51 was positioned once on the tissue to be examined.
[0081] The combined / superimposed movement of rotation and translation movement of the transfer element 110 can now be transferred to the coupling section 150, which is provided, for example, at the end of the transfer element 110, which can be located, for example, in the region of the transfer section 112, wherein for the further description of the transfer of the movement from the transfer element 110 to the biopsy blade 50, reference is made to the following Figs. 4 - 6.
[0082] Fig. 4 shows a detailed section of the further exemplary representation of the embodiment of the biopsy mechanism 100, in particular with regard to the transmission of the combined rotation and translation movement of the transfer element 110 to the biopsy blade 50 by means of the coupling section 150, in a sectional view.
[0083] The conversion element 110 is effectively connected to the coupling element 151 (for example by clamping, gluing / welding, etc.), so that the movement (combination of rotational and translational movement) of the conversion element 110 is transmitted directly to the coupling element 151 of the coupling section 150 (Vrot of the conversion element 110 is equal to Vrot of the coupling element 151 and Rrot of the conversion element 110 is equal to Rrot of the coupling element 151; the same applies to the translational movements Vtrans and Rtrans).
[0084] The coupling portion 150 further comprises a connecting element 152 which is operatively connected to the biopsy blade 50 (for example, again by clamping, gluing / welding, etc.).
[0085] Both the coupling element 151 and the connecting element 152 are designed such that the rotational movement of the conversion element 110 (in the first rotational direction) and thus that of the coupling element 151 during the forward movement V is transmitted from the coupling element 151 to the connecting element 152. For this purpose, the coupling element 151 and the connecting element 152 can have corresponding structures that are brought into engagement with one another in order to transmit the rotational movement (in the first rotational direction). Reference is made to Fig. 6 for this purpose.
[0086] In addition to the rotational movement of the coupling element 151, the translational movement (in the first translational direction) of the coupling element 151 is also transmitted to the connecting element 152 during the forward movement V, since the coupling element 151 is pushed towards the connecting element 152 by the combined rotational and translational movement of the conversion element 110 in the forward movement V, then brought into contact with the connecting element 152 and, upon further forward movement V, this is pushed in the forward direction V (in the first translational direction) by the coupling element 151.
[0087] At the same time, the rotational movement of the coupling element 151 is transmitted to the connecting element 152, so that the biopsy blade 50 also makes a combined rotational and translational movement (rotating forward movement of the biopsy blade 50) during the forward movement V, i.e. when penetrating the tissue to be examined, whereby the blades 51a (see Figs. 10a, 10b) of the biopsy blade 50 cut into the tissue to be examined (due to the rotational movement) and at the same time penetrate deeper into the tissue to be examined (due to the simultaneous translational movement).
[0088] This simultaneously results in the tissue severed by the rotating forward movement of the biopsy blade 50 being able to be received in the inner section 51d (see Figs. 10a, 10b) of the biopsy cutting head 51 if the stylet 20 has previously been retracted in order to release / open the inner section 51d of the biopsy cutting head 51 for receiving tissue.
[0089] For the backward movement R of the biopsy blade 50, the force introduction element 200 and thus the translation element 110 are rotated accordingly in the opposite direction R (in the second rotation direction), whereby the translation element 110 is simultaneously moved translationally in the opposite direction R (in the second translation direction), which also leads to an opposite combined rotation and translation movement of the coupling element 151.
[0090] In this case, the coupling element 151 is moved away from the connecting element 152, and a rotational movement of the coupling element 151 in the backward movement Rrot is no longer transmitted to the connecting element 152 and thus no longer to the biopsy blade 50 (rotation in the second rotational direction of the transfer element 110 / coupling element 151 is not transmitted to the connecting element 152). The structures engaged during the forward movement V of the biopsy blade 50 (see Fig. 6) are disengaged during the backward movement, thereby decoupled from the rotational movement Rrot of the coupling element 151 / the transfer element 110 from the connecting element 152 / from the biopsy blade 50 (from the biopsy blade head 51).
[0091] In order to nevertheless withdraw / remove the biopsy cutting head 51 with the acquired tissue from the tissue to be biopsied, the coupling element 151 and the connecting element 152 are accommodated by a transmission element 153, which surrounds the two elements (coupling element 151 and connecting element 152) like a type of cage, for example, and in which the connecting element 152 is mounted / received, for example, exclusively rotatably, and in which the coupling element 151 is mounted / received for rotation and translational movement. Due to the additional translational mobility of the coupling element 151 relative to the transmission element 153, the engagement of the two elements (coupling element 151 and connecting element 152) can be released or disengaged.The path length of the translational movement of the coupling element 151 relative to the transmission element 153 is limited, so that, for example, as soon as the engagement of the two elements 151, 152 is released, the coupling element 151 abuts against an inner section of the transmission element 153 and with a further backward movement R of the coupling element 151 (and thus also translational backward movement Rtrans of the coupling element 151 in the second translation direction), the transmission element 153 is also moved back translationally and the translational backward movement Rtrans of the transmission element 153 is transferred to the connecting element 152 and thus to the biopsy blade 50.
[0092] It should be mentioned at this point that during the forward movement V the transmission element 153 is carried along translationally with the two elements (coupling element 151 and connecting element 152), but a transmission of force and / or movement via the transmission element 153, for example, does not need to take place.
[0093] To ensure that the transmission element 153 is movable purely translationally, the transmission element 153 may further comprise protruding portions 153a (see Fig. 5) which engage with the surrounding structure of the exemplary biopsy device 1000 and can be moved purely translationally therein, but prevent rotation of the transmission element 153.
[0094] Fig. 5 shows a further exemplary representation of the embodiment of the biopsy mechanism 100 in a sectional view as well as further details of the coupling section 150.
[0095] In this Fig. 5, the elements advantageous for the biopsy mechanism 100 are shown again separately from the remaining surrounding structure of the exemplary biopsy device 1000 and briefly described.
[0096] First, a rotation applied manually by the user to the force introduction element 200 can be transmitted through the force transmission section 220 to the conversion element 110, which, by means of a conversion section 112, for example designed as a thread, and the similarly designed counter element 120, which is provided in a fixed and positional manner within the biopsy device 1000, simultaneously performs a translational movement (depending on the rotational movement) in addition to the rotational movement, wherein the additional translational movement of the conversion element 110 is decoupled from the force introduction element 200.
[0097] This combination of rotational and translational movement is transmitted by means of the coupling element 151 of the coupling section 150, in particular during the forward movement V directly through contact (engagement) with the connecting element 152 to the connecting element 152, which in the forward movement V also makes a combined rotational and translational movement, which the connecting element 152 transmits directly to the biopsy cutting edge 50 and thus to the biopsy cutting head 51, so that the biopsy cutting head 51, when penetrating the tissue 50 to be biopsied, cuts into the tissue to be examined (due to the rotational movement) and at the same time and in dependence on the rotation, penetrates deeper into the tissue to be examined (due to the simultaneous translational movement).
[0098] In contrast, during the backward movement R, i.e. the movement of the biopsy cutting head 51 out of the tissue to be biopsied, a purely translational movement of the biopsy cutting head 51 is carried out in order to remove the tissue sample taken in the biopsy cutting head 51 from the surrounding tissue as gently as possible.
[0099] For this purpose, the coupling section 150 is configured, for example, such that the coupling element 151 releases the (direct) engagement with the connecting element 152 through the translational movement of its combined rotational and translational movement, and the translational movement of the coupling element 151 in the reverse direction R is transmitted to the connecting element 152 via the transmission element 153. For this purpose, the coupling element 151 can be accommodated in the transmission element 153 so that it can be moved both rotationally and translationally, while the connecting element 152 can be accommodated in the transmission element 153 so that it can be moved purely rotationally.
[0100] To ensure that the transmission element 153 cannot rotate, protruding sections 153a are provided, for example, which can engage with the surrounding structure of the exemplary biopsy device 1000 and thus allow only a translational but not a rotational movement of the transmission element 153.
[0101] Fig. 6 shows a further exemplary representation of an embodiment of the coupling section 150 with the connecting element 152 and the coupling element 151, but without the transmission element 153. The connecting element 152 and the coupling element 151 are configured to come into contact with one another upon rotation of the conversion element 110 in the first rotational direction (here the forward direction Vrot) and thereby to transmit the rotation of the conversion element 110 through the coupling element 151 to the connecting element 152, and to release the contact with one another upon rotation of the conversion element 110 in the second rotational direction (here the reverse direction Rrot) and thereby to decouple the rotation of the conversion element 110 from the connecting element 152.
[0102] Figure a) of Fig. 6 once again shows the state in which the coupling element 151 is not (yet) engaged with the connecting element 152. Here, the structures or engagement sections 151a, 152a are already shown, which, as in this example, can consist of a combination of protruding sections 151a, for example on the side of the coupling element 151, and recesses 152a, for example on the side of the connecting element 152.
[0103] In addition, the at least one engagement section 151a of the coupling element 151 is formed on the side of the coupling element 151 facing the connecting element 152, and the at least one engagement section 152a of the connecting element 152 is formed on the side of the connecting element 152 facing the coupling element 151. As shown, it can also be advantageous if both elements (coupling element 151 and connecting element 152) are designed such that the stylet 20 can be guided substantially centrally through both elements 151, 152 and then inserted into the biopsy blade 50 at the location of the connecting element 152, which is connected to the biopsy blade 50.
[0104] Furthermore, as is also shown somewhat more clearly in illustration b) of Fig. 6, the respective at least one engagement section 151a, 152a of the connecting element 152 and the coupling element 151 can be substantially tooth-shaped or wedge-shaped, wherein the tooth or wedge shape is designed / configured to transmit the rotation in the first rotational direction (i.e. in the forward direction Vrot) of the transfer element 110 from the coupling element 151 to the connecting element 152 and thus to the biopsy blade 50.
[0105] It should be noted at this point that, in addition to the exemplary tooth and / or wedge shapes, other shapes may also be possible for transmitting the rotation in the forward direction V from coupling element 151 to connecting element 152. Furthermore, the number of teeth / wedges may be, for example, one, two, three, four, or more.
[0106] Fig. 7 shows an exemplary representation of an embodiment of the telescopically adjustable device section 540, 440, in particular the locking section 500, 400 for locking the respective telescopically adjustable device section 540, 440. Since both locking sections 500, 400 are essentially constructed in the same way (differences are pointed out separately), the following description applies to both device sections 540, 440 / locking sections 500, 400, even if in Fig. 7 essentially only the device section 540 / locking section 500 is shown.
[0107] For this purpose, the at least one telescopically adjustable device section 540, 440 can be configured to adapt the biopsy device 1000 to a length of an endoscope (which is to be used, for example, for the respective biopsy) or to position the biopsy cutting head 51 of the biopsy device 1000 to the tissue to be biopsied (for example, by a purely translational movement).
[0108] The locking section 500, 400, which is designed to lock the respective telescopically adjustable device section 540, 440 to the respective adaptation of the biopsy device 1000, can have a rotatably mounted clamping section 521, 421 (of the clamping element 520, 420) (see, for example, figure a) of Fig. 7, which shows the state of a released lock), which is designed to generate the locking of the at least one telescopically adjustable device section 540, 440 by a rotating change in position relative to the locking section 500, 400, since a clamping and / or friction force for the locking can be generated by the rotating change in position relative to the locking section 500, 400.
[0109] For this purpose, the locking section 500, 400 can, for example, have a corresponding manually operable element 510, 410, which can be designed, for example, as a lever 510, 410. It should be noted that the element 510, 410 can also have a shape other than that of a lever, for example, the shape of a cylindrical element with knurling.
[0110] In addition, it can be advantageous if the rotatably mounted clamping section 521, 421 is designed as an elliptical clamping section 521, 421 (see, for example, figure b) of Fig. 7, which shows the state of a released lock), so that upon a rotational change in position of this clamping section 521, 421, for example, the longer regions of the elliptical clamping section 521, 421 can clamp with a corresponding clamping surface 541, 441 of the respective telescopically adjustable device section 500, 400, so that the set length / position of the telescopically adjustable device section 500, 400 is locked. For this purpose, in figures a) and b) of Fig. 7, the lever 510, 410 would be positioned transversely to the longitudinal direction of the biopsy device 1000.
[0111] The respective clamping sections 521 and 421 may have different configurations. For example, clamping section 521 may have a smaller elliptical shape than clamping section 421, or vice versa. Furthermore, the shape itself may differ between the two clamping sections 521, 421. While one of the two clamping sections 521, 421 may have an elliptical shape, the other of the two clamping sections 521, 421 may, for example, have a diamond shape.
[0112] In addition, the clamping sections 521, 421 can comprise different materials. For example, both clamping sections 521, 421 can comprise a thermoplastically flexible material, which also deforms slightly elastically when the clamping section 521, 421 is clamped to the respective clamping surface 541, 441.
[0113] Furthermore, it may be advantageous if the corresponding clamping surfaces 541, 441 of the respective telescopically adjustable device section 500, 400 have a profiling / structure that makes the clamping of the clamping section 521, 421 more secure. For this purpose, for example, a serrated profiling of the corresponding clamping surface 541, 441 may prove advantageous, since the clamping section 521, 421 can advantageously rotate into the serrated profiling due to the rotational movement to create the locking / clamping, and at the same time, an independent release of the clamping can be effectively prevented by the profiling and can only be released by a renewed actuation of the manually operable element 510, 410 (lever 510, 410).
[0114] Of course, in addition to the serrated shape, other profiles of the clamping surfaces 541, 441 may also be advantageous, for example, recesses at defined intervals, with the clamping sections 521, 421 screwing into the recesses. This could, for example, be used for a stepwise adjustment of the telescopically adjustable device sections 540, 440, if appropriate. However, other forms of profiling that enable improved friction between the clamping section 521, 421 and the respective clamping surface 541, 441 may also be advantageous.
[0115] The rotatable mounting of the clamping element 520, 420 can, for example, advantageously be achieved by a bearing element 530 in the case of the telescopically adjustable device section 540, wherein the bearing element 530 can further be configured to be connected to the structure of the biopsy device 1000 surrounding the biopsy mechanism 100, in particular to the end face of the biopsy device 1000 directed towards the biopsy cutting head 51 of the biopsy cutting blade 50 (for example as a type of flange).
[0116] Furthermore, in the region of the telescopically adjustable device section 540, in particular in the region of the locking section 500, the tubular guide element / guide tube 560 can be provided or begin here, into which the biopsy blade 50 is inserted from the connecting element 152 of the coupling section 150 and extends in the direction of the mounting section 600. For fastening the guide tube 560 within the telescopically adjustable device section 540, a mounting bushing 550 can also be provided, which holds the guide tube 560 substantially centrally of the telescopically adjustable device section 540.
[0117] The guide tube 560 further extends through the telescopically adjustable device section 440, which can be locked by means of the locking section 400, wherein for this purpose the telescopically adjustable device section 540 can have a bearing section 531 for guiding the clamping element 420 (see, for example, figure a) of Fig. 7).
[0118] To guide the telescopically adjustable device section 440 within the telescopically adjustable device section 540, the telescopically adjustable device section 540 can further comprise an inwardly projecting guide section 542, wherein the telescopically adjustable device section 440 can comprise a corresponding recess / cutout on its outer side. This allows the telescopically adjustable device section 440 to be guided within the telescopically adjustable device section 540 and secured against rotation.
[0119] Fig. 8 shows an exemplary representation of the embodiment of the stylet operating element 300, which is accommodated in the force introduction element 200.
[0120] The force introduction element 200 of the biopsy device 1000 can, for example, have a receptacle for the stylet operating element 300, in particular a through opening 222 of the force transmission section 220 extending substantially centrally in the axial direction of the biopsy device 1000, which is configured to receive the stylet operating element 300 and also has two locking points / recesses 222a, 222b, which are provided substantially at the two ends of the through opening 222.
[0121] For insertion into this opening 222, the stylet operating element 300 can in turn have a stylet receiving section 320, which can extend longitudinally from the operating section 310 parallel to the stylet 20 or in the direction of the distal end of the exemplary biopsy device 1000. A protruding section 321 can be formed at the distal end of the stylet receiving section 320, which is further configured to engage the two locking points / recesses 222a, 222b of the opening 222, so that the stylet operating element 300, and thus also the stylet 20 itself, can be fixed in two positions in the longitudinal direction of the biopsy device 1000.
[0122] These two positions of the stylet 20 can be, for example, if the stylet 20 is to release / open the inner section 51d of the biopsy cutting head 51 (see Figs. 10a, 10b) for the reception of tissue, then the stylet 20 is locked into the position / recess 222b by means of the protruding section 321 of the stylet operating element 300, which is furthest from the distal end of the biopsy device 1000, and if the stylet 20 is to close the inner section 51d of the biopsy cutting head 51 or to press the collected tissue out of the inner section 51a, then the stylet 20 is locked into the position / recess 222a by means of the protruding section 321 of the stylet operating element 300, which is closest to the distal end of the biopsy device 1000.
[0123] To hold the stylet 20 by the stylet control element 300, the stylet receiving section 320 of the stylet control element 300 can have a holding section 320a in which the stylet 20 can be clamped and secured. However, other securing options can also be provided, for example, clamping by means of a screw or gluing the stylet 20 to the stylet control element 300.
[0124] The recess 221 shown here of the force transmission section 220 of the force introduction element 200 serves to transmit the rotational force / rotation of the force introduction element 200 to the transfer element 110, wherein a mobility of the transfer element 110 along the longitudinal direction of the force transmission section 220 (axial direction of the biopsy device 1000) relative to the force introduction element 200 is provided, since a corresponding protruding section 111 of the transfer element 110 can move therein in the longitudinal direction of the biopsy device 1000 and no force is transmitted in the longitudinal direction of the biopsy device 1000.
[0125] Fig. 9 shows an exemplary representation of an embodiment of a mounting section 600 of the biopsy device 1000 for exemplary mounting on an endoscope.
[0126] For this purpose, the mounting section 600 of the biopsy device 1000 can have a handle element 610, by means of which the user can manually connect and fix the biopsy device 1000 to the corresponding endoscope. For this purpose, the user can, for example, rotate the handle element 610 or perform a combined push-turn movement (for example, like a bayonet lock) to establish the connection / fixation of the biopsy device 1000 to the endoscope.
[0127] In addition, the mounting section 600 can comprise a mounting element 620, which can be provided within the handle element 610 and have the corresponding connection option (for example, a thread for screwing the biopsy device 1000 to the endoscope or part of a bayonet lock for fixing the biopsy device 1000 to the endoscope by means of a push-and-turn movement). The mounting element 620 can, for example, be pressed into the handle element 610 (but it can also be fixed in the handle element 610 in another way).
[0128] Furthermore, it can be seen that when the two telescopically adjustable device sections 540, 440 are substantially fully extended, the guide tube 560 for guiding the biopsy blade 50 essentially ends in the region of the mounting section 600. If the telescopically adjustable device sections 540, 440 were not fully extended, the guide tube 560 would extend further beyond the mounting section 600, since the guide tube 560 is held slidingly by the mounting element 620.
[0129] The stylet 20 here only shows the state when it is locked into the locking point / recess 222a by means of the stylet operating element 300 (see Fig. 8), which is closest to the distal end of the biopsy device 1000.
[0130] Fig. 10a shows in the figures a) to c) an exemplary representation of an embodiment of a biopsy cutting edge 50 with corresponding cutting edge geometries of the biopsy cutting head 51 and a hollow shaft 52 which is connected to the biopsy cutting head 51.
[0131] In this case, as shown by way of example in figure a) of Fig. 10a, the biopsy cutting head 51 of the biopsy blade 50 can be designed as a hollow cylinder and have at least one cutting section with a cutting edge 51a at one end facing the tissue to be biopsied during the biopsy. The at least one cutting edge 51a is provided on the biopsy cutting head 51 such that upon rotation of the biopsy blade 50 in the forward movement V (as a superposition of the rotation in the first rotational direction and the translation in the first translational direction), the at least one cutting edge 51a cuts into the tissue to be examined.
[0132] Furthermore, in order to enable easier penetration of the biopsy cutting head 51 or the cutting edges 51a into the tissue to be biopsied, the at least one cutting edge section can be substantially wedge-shaped and have a cylindrical outer surface common to the biopsy cutting head 51, as shown by way of example in illustration b) of Fig. 10a. Here, the curved shape of the rear surface 51c of the at least one cutting edge section can be seen, wherein the curved shape can be dependent on the cylindrical shape of the outer surface of the biopsy cutting head 51. Furthermore, it can be advantageous if, for example, the at least one cutting edge section, in particular the cutting edge 51a and the rear surface 51c, are designed to taper distally at an angle α1, α2 of, for example, 15° to 30°, preferably at an angle α1, α2 of 20° to 25°, and particularly preferably at an angle α1, α2 of 22.5°.This can significantly facilitate the penetration of the biopsy cutting head 51 into the tissue to be biopsied and somewhat reduce the mechanical stress on the biopsy mechanism 100. However, it is also possible for the two angles a1, a2 to be formed differently.
[0133] In addition, the cutting edge 51a can extend parallel to a rotation axis A of the biopsy cutting head 51. However, it can also be advantageous if the cutting edge 51a has a slight bevel, for example in a range of 1 - 5°, in particular 3°. This can be advantageous for the actual cutting process in order to more easily sever the tissue to be biopsied or to more easily detach the tissue to be examined from the surrounding tissue and thus continue to keep mechanical stress on the biopsy mechanism 100 as low as possible. Furthermore, as illustrated in figures a) - c) of Fig. 10a, the at least one cutting edge 51a can have a grind 51b, in particular a one-sided grind 51b. For this purpose, for example, the one-sided grind 51b of the cutting edge 51a can be an inner side of the cutting section (inner section 51d of the biopsy cutting head 51, see, for example, figure c) of Fig.10a) and an outer contour / outer side of the cutting edge 51a essentially corresponds to the outer side of the cutting section, in particular of the biopsy cutting head 51, so that the outer sides of the cutting sections remain cylindrical.
[0134] In addition, the biopsy cutting head 51 can advantageously have at least two cutting sections / cutting edges 51a, which are, for example, rotationally symmetrical to the rotation axis A on the biopsy cutting head 51. However, it can also be advantageous if more than two cutting sections / cutting edges 51a, for example, three or four, are provided on the biopsy cutting head 51.
[0135] Furthermore, it may be advantageous if the biopsy cutting head 51 has a structure and / or a coating on the outside / outer surface that enables advantageous reflection of the ultrasound at the biopsy cutting head 51 and thus better detectability during ultrasound-guided biopsies.
[0136] It may also be advantageous if the biopsy device 1000 is further configured to perform the acquisition of a portion of the tissue to be biopsied substantially under an ambient pressure of the biopsy device 1000 within the biopsy cutting head 51. This means that no negative pressure is required or applied within the biopsy cutting head 51 for the removal of the tissue sample from the surrounding tissue.
[0137] This can be advantageously used to connect the biopsy cutting head 51 and the connecting element 152 of the coupling section 150 using a hollow shaft 52, which, for example, is tubular and bendable / flexible and has a fluid-permeable (permeable, for example, to gases / air, but also to liquids) outer surface. For this purpose, the outer surface of the hollow shaft 52 can be formed, for example, from a wound and / or woven material, for example from a wound flat or round wire (for example, made of stainless steel for sterilization). Furthermore, with a flexible hollow shaft 52, it can of course be advantageous if the stylet 20 is also bendable / flexible. Figures a) and b) of Fig. 10b show exemplary representations of further biopsy blades 50 with other cutting geometries of the biopsy cutting head 51.
[0138] For example, in the illustrations a) and b) of Fig. 10b, a biopsy cutting head 51 is shown which advantageously has at least two cutting sections / cutting edges 51a which are designed as shown in Fig. 10a, wherein the cutting edge 51a extends at an angle a3, a4 with respect to a longitudinal axis B of the biopsy cutting head 51 lying in a lateral surface of the hollow cylinder of the biopsy cutting head 51.
[0139] For example, as shown in Figure a) of Fig. 10b, the angle a3 of the cutting edge 51a can be designed such that the angle a3 opens in the direction of the distal end of the biopsy cutting head 51.
[0140] In contrast to figure a) of Fig. 10b, as shown in figure b) of Fig. 10b, the angle a4 of the cutting edge 51a can be designed such that the angle a4 closes in the direction of the distal end of the biopsy cutting head 51.
[0141] Here, the angle a3, a4 can be formed, for example, in a range of 1° - 10°, preferably in the range of 3° - 8°, and particularly preferably in the range of 5° - 6°. However, the angles a3, a4 can also be formed, for example, in a range of 1° - 4°, preferably in the range of 5° - 7°, and particularly preferably in the range of 8° - 10°. Furthermore, the angles a3, a4 can also have the specific angle values, for example 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, or even intermediate values (for example 1.5°, 2.5°, 3.5°, 4.5°, etc.).
[0142] It should be noted that only examples or exemplary embodiments of the present disclosure, as well as technical advantages, have been described above in detail with reference to the accompanying figures. However, the present disclosure is in no way limited or restricted to the exemplary embodiments described above and their design features or their described combinations, but further encompasses modifications of the exemplary embodiments, in particular those encompassed by modifications of the features of the described examples or by combination or partial combination of individual or several of the features of the described examples within the scope of the independent claims. List of reference symbols
[0143] 20 Stylet
[0144] 50 biopsy blades
[0145] 51 Biopsy cutting head
[0146] 51a Cutting edge
[0147] 51b Cutting edge grinding
[0148] 51c rear surface of the cutting section
[0149] 51d Inner section of the biopsy cutting head for taking the tissue sample
[0150] 52 Hollow shaft / flexible hollow shaft
[0151] 100 Biopsy mechanism
[0152] 110 Implementation element
[0153] 111 inwardly projecting section
[0154] 112 Implementation section / thread
[0155] 120 stationary element / counter element
[0156] 150 coupling section
[0157] 151 Coupling element
[0158] 151a protruding section / intervention section
[0159] 152 connecting element
[0160] 152a Recess / intervention section
[0161] 153 transmission element
[0162] 153a preceding section
[0163] 200 force introduction element
[0164] 210 Force introduction section
[0165] 220 power transmission section
[0166] 221 Deepening
[0167] 222 continuous opening
[0168] 222a Rest area / depression
[0169] 222b Rest area / depression
[0170] 300 Stylet control element
[0171] 310 Operating section
[0172] 320 Stylet receiving section 320a Holding section
[0173] 321 preceding section
[0174] 400 locking section
[0175] 410 actuatable element / lever
[0176] 420 clamping element
[0177] 421 clamping section
[0178] 440 telescopically adjustable device section
[0179] 441 clamping surface
[0180] 500 locking section
[0181] 510 actuatable element / lever
[0182] 520 clamping element
[0183] 521 clamping section
[0184] 530 bearing element
[0185] 531 camp section
[0186] 540 telescopically adjustable device section
[0187] 541 clamping surface
[0188] 542 management section
[0189] 550 mounting bushing
[0190] 560 tubular guide element / guide tube
[0191] 600 assembly section
[0192] 610 handle element
[0193] 620 mounting element
[0194] 800 handle section
[0195] 900 Position indicator section
[0196] 1000 biopsy device
[0197] A Rotation axis of the biopsy cutter / biopsy cutting head
[0198] B Longitudinal axis in a lateral surface of the hollow cylinder of the biopsy cutting head R Backward movement of the respective element
[0199] Rrot rotational backward movement of the respective element
[0200] Rtrans translational backward movement of the respective element
[0201] V Forward movement of the respective element Vrot rotational forward movement of the respective element
[0202] Vtrans translational forward movement of the respective element al / a2 angle between the cutting edge and the rear surface of the cutting section a3 / a4 angle between the cutting edge and the surface of the hollow cylinder of the
[0203] Biopsy cutting head longitudinal axis
Claims
Patent claims 1. A biopsy device, comprising: a translation element that is rotatably movable by an external force and translationally movable due to the rotation, wherein the translation element is translationally movable in a first translation direction when rotated in a first rotational direction, and is translationally movable in a second translational direction opposite to the first rotational direction when rotated in a second rotational direction opposite to the first translational direction, a biopsy cutting head that is configured to receive a tissue sample, and a coupling section that is arranged between the biopsy cutting head and the translation element and is configured to transmit the rotation of the translation element in the first rotational direction and the translation of the translation element in the first translational direction to the biopsy cutting head for a first partial movement of the biopsy cutting head.
2. Biopsy device according to claim 1, wherein the coupling section is further configured to transmit the translation of the translation element in the second translation direction for a second partial movement of the biopsy cutting head to the biopsy cutting head and thereby to decouple the rotation of the translation element in the second rotation direction from the biopsy cutting head.
3. Biopsy device according to claim 2, wherein the first partial movement of the biopsy cutting head is a rotary forward movement of the biopsy cutting head into the tissue to be biopsied to pick up a part of the tissue to be biopsied, and the second partial movement of the biopsy cutting head is a backward movement of the biopsy cutting head with the picked up part of the tissue to be biopsied out of the tissue.
4. Biopsy device according to claim 2 or 3, wherein the biopsy device is further configured to carry out the acquisition of a part of the tissue to be biopsied substantially under an ambient pressure of the biopsy device within the biopsy cutting head.
5. Biopsy device according to one of the preceding claims, wherein the coupling section comprises a connecting element which is operatively connected to the biopsy cutting head, and a coupling element which is arranged between the connecting element and the translation element and is operatively connected to the translation element, wherein the connecting element and the coupling element are configured to come into contact with one another upon rotation of the translation element in the first rotational direction and thereby to transmit the rotation of the translation element to the connecting element through the coupling element, and to release the contact with one another upon rotation of the translation element in the second rotational direction and thereby to decouple the rotation of the translation element from the connecting element.
6. Biopsy device according to claim 5, wherein when the connecting element comes into contact with the coupling element, both elements engage with each other, the connecting element and the coupling element each having at least one engagement section for this purpose.
7. The biopsy device according to claim 6, wherein the at least one engagement portion of the coupling element is formed on the side of the coupling element facing the connecting element, and the at least one engagement portion of the connecting element is formed on the side of the connecting element facing the coupling element.
8. Biopsy device according to claim 6 or 7, wherein the respective at least one engagement portion of the connecting element and the coupling element is substantially tooth-shaped or wedge-shaped, and wherein the tooth or wedge shape is configured to transmit the rotation in the first rotational direction of the conversion element from the coupling element to the connecting element.
9. Biopsy device according to one of claims 5 to 8, wherein the coupling section has a transmission element in which the connecting element and the coupling element are received, wherein the transmission element is configured to transmit the translation of the conversion element to the connecting element via the coupling element upon rotation of the conversion element in the second rotational direction.
10. Biopsy device according to claim 9, wherein the connecting element is received in the transmission element exclusively rotatably and the coupling element is received in the transmission element rotatably and translationally movable.
11. Biopsy device according to claim 9 or 10, wherein the transmission element is translationally movable within the biopsy device and secured against rotation.
12. Biopsy device according to one of the preceding claims, further comprising: a force introduction element which is rotatable in the first and second rotational directions by the introduction of an external force and is configured to transmit the rotation to the translation element.
13. The biopsy device according to claim 12, wherein the external force is a force applied manually by a user of the biopsy device to rotate the force application element.
14. A biopsy device according to any one of the preceding claims, wherein the translation element has a first portion with a thread that engages an element fixed within the biopsy device to convert the rotation of the translation element into the translation of the translation element superimposed on the rotation.
15. Biopsy device according to claim 12, wherein the translation element has a second portion which interacts with the force introduction element such that the rotation of the force introduction element is transferred to the conversion element, whereby the force introduction element is decoupled from the translation of the conversion element.
16. Biopsy device according to one of the preceding claims with claim 5, wherein the biopsy device is further configured such that the connecting element, the coupling element, the conversion element and the force introduction element rotate at the same angular velocity when rotating in the first direction of rotation, and the coupling element, the conversion element and the force introduction element rotate at the same angular velocity when rotating in the second direction of rotation.
17. Biopsy device according to one of the preceding claims with claim 5, wherein the biopsy device is further configured such that the connecting element, the coupling element, the conversion element and the force introduction element rotate in the same direction of rotation when rotating in the first direction of rotation, and the coupling element, the conversion element and the force introduction element rotate in the same direction of rotation when rotating in the second direction of rotation.
18. Biopsy device according to one of the preceding claims, wherein the biopsy cutting head is designed as a hollow cylinder and has at least one cutting section with a cutting edge at one end facing the tissue to be biopsied, wherein the at least one cutting section is substantially wedge-shaped and has a cylindrical outer side common to the biopsy cutting head, and wherein the cutting edge extends parallel to a rotation axis of the biopsy cutting head or at an angle to a longitudinal axis of the biopsy cutting head lying in a lateral surface of the hollow cylinder.
19. Biopsy device according to claim 18, wherein the angle is in a range of 1° - 10°, preferably in the range of 3° - 8°, and particularly preferably in the range of 5° - 6°.
20. A biopsy device according to claim 18 or 19, wherein the cutting edge has a single-sided grind.
21. Biopsy device according to claim 20, wherein the one-sided grinding of the cutting edge faces an inner side of the cutting section of the biopsy cutting head and an outer contour of the cutting edge essentially corresponds to the outer side of the cutting section, in particular of the biopsy cutting head.
22. Biopsy device according to one of claims 18 to 21, wherein the at least one cutting section is formed to taper distally at an angle of 15° to 30°, preferably at an angle of 20° to 25°, and particularly preferably at an angle of 22.5°.
23. Biopsy device according to one of claims 18 to 22, wherein the biopsy cutting head has two cutting sections which are rotationally symmetrical on the biopsy cutting head.
24. A biopsy device according to any one of the preceding claims, further comprising: a stylet disposed within the biopsy cutting head and configured to be retracted to a first position for the first partial movement of the biopsy cutting head to enable the biopsy cutting head to capture a portion of the tissue to be biopsied and to be advanced to a second position to expel the captured portion of the tissue to be biopsied from the biopsy cutting head.
25. The biopsy device of claim 24, wherein a force introduction element of the biopsy device, through which the external force is transmitted to the translation element, has a receptacle for a stylet operating element that is operatively connected to the stylet, and wherein the force introduction element has at least two locking points for locking the stylet operating element to position the stylet in the first and second positions.
26. Biopsy device according to one of the preceding claims, further comprising: at least one telescopically adjustable device section which is configured to adapt the biopsy device to a length of an endoscope or to position the biopsy cutting head of the biopsy device to the tissue to be biopsied, and a locking section which is configured to lock the at least one telescopically adjustable device section to the respective adaptation of the biopsy device, wherein the locking section has a rotatably mounted clamping section which is configured to produce the locking of the at least one telescopically adjustable device section by a rotating change in position relative to the locking section. ZI. Biopsy device according to claim 26, wherein the clamping section is rotated by the change in position relative to the Locking section generates a clamping and / or friction force for locking the at least one telescopically adjustable device section.
28. Biopsy device according to claim 26 or ZI, wherein the rotatably mounted clamping section is designed as an elliptical clamping section.
Citation Information
Patent Citations
Biopsy Device with Sliding Cutter Cover
US20100160821A1
System and method for fine needle aspiration
US20150005662A1
Helical driven rotating tissue collection
US20160081675A1
Rotating needle driver and apparatuses and methods related thereto
US20170252115A1
Biopsy instrument, kit of parts and method
WO2021204376A1