Biopsy instruments, complete sets of parts

Abstract

The kit and biopsy instrument (1) comprise a base member (10) extending from a proximal end (10a) along a central geometric axis (A) to a distal end (10b), wherein at least a distal portion (10b') of the base member (10) is formed as an elongated hollow tube (10'), the distal end (10b) being intended to be rotated and at least partially inserted into a tissue (50) from which a biopsy is to be obtained, wherein the elongated hollow tube (10') is provided with a distally facing circular cutting edge (11) defining a mouth (10c) of the distal end (10b) of the elongated hollow tube (10'), wherein the elongated hollow tube (10') has a hollow elongated tubular sample acquisition portion (10b') at the distal portion (10b') of the elongated hollow tube (10'), the hollow elongated tubular sample acquisition portion having a smooth inner surface (12). The present disclosure also relates to a method of obtaining a biopsy.

Description

Field of the Invention

[0001] The invention also relates to a kit of parts.

[0002] The present invention relates to a biopsy instrument.

[0003] The present invention also relates to methods of obtaining a biopsy. Technical Background

[0004] A biopsy is a medical test usually performed by a physician that involves the sampling of cells or tissue for examination. A biopsy is usually obtained using a biopsy instrument that is inserted into the patient's body via an endoscope. There are a variety of endoscopic biopsy instruments on the market today, most of which are either biopsy forceps that pinch off a tissue sample, or thin needles that apply negative pressure to aspirate cells.

[0005] For some diagnostic purposes, the millimeter-sized sample that can be retrieved using the biopsy forceps is sufficient, but for some types of lesions and tumors (such as relatively deep lesions or deep-growing tumors), such small and superficial millimeter-sized samples are insufficient to make a diagnosis. Fine needles are usually able to reach deeper tumors, but can only retrieve a small number of scattered cells, thereby limiting the diagnostic ability.

[0006] When using an endoscopic biopsy instrument to collect a tissue sample, the instrument is inserted into the working channel of the endoscope and advanced to the biopsy site. After obtaining the tissue sample, the endoscopic biopsy instrument is retracted from the endoscope so that the tissue sample can be placed in a storage unit for evaluation by a pathologist.

[0007] Biopsy is currently the main diagnostic tool used to determine the malignancy of tumor growth. As cancer treatment methods improve and improve, the number of biopsies required for diagnosis is also increasing. Before the best treatment method can be determined, the spread and density of malignant cells need to be evaluated. For example, 20 to 30 biopsies may be required in the diagnosis of laryngeal or esophageal cancer, which is a time-consuming and inconvenient process for both patients and doctors. In addition, biopsy forceps separate tissue samples from the patient's body by tearing, which risks damaging the tissue sample and makes it more difficult to evaluate the tissue sample. The fine needle provides a small amount of cells that cannot be prepared by conventional histological methods and usually requires more advanced ultrasound endoscopy equipment.

[0008] In this context one may refer to WO201166470, which discloses an endoscopic biopsy instrument having a forceps with a storage cavity for multiple biopsies. The biopsies are conveyed upward into the storage cavity using suction applied when retrieving the sample.

[0009] Another technique sometimes used is to provide a needle having a closed distal end and having an opening in a circumferential surface near the distal end. In such a needle, suction is used, which draws a portion of tissue into the opening in the circumferential surface. A reciprocating cutting tool is provided inside the needle, which passes back and forth through the opening and cuts the tissue portion inside the circumferential surface. Examples of such techniques are shown in US20100152756 and US20060074343.

[0010] In WO200197702, a biopsy instrument is disclosed in which an outer needle or cannula is inserted into the tissue and in contact with the lesion, whereby continuous suction applied at the proximal end of the cannula is used to fix the lesion to the distal end of the cannula. While maintaining the suction force that holds the lesion in place, a second medical device (e.g., a biopsy needle or a cryoprobe) is inserted through an airtight seal at the proximal end of the instrument and through the cannula to the lesion. In US2013 / 0223702 A1, various types of biopsy instruments are also disclosed that use forceps, an auger, or a vacuum to draw tissue samples into the instrument.

[0011] A further problem with the above disclosed techniques is that they rely on the application of suction, which complicates the apparatus.

[0012] It would therefore be advantageous to have a biopsy instrument that allows a straightforward and robust design and that is capable of retrieving a tissue sample in a quantity sufficient for diagnosis in a short time. Furthermore, it would be advantageous if the tissue sample provided by the biopsy instrument was coherent. SUMMARY OF THE INVENTION

[0013] One object of the present invention is to provide a biopsy instrument which allows a straightforward and robust design and which is able to retrieve a tissue sample in a short time in an amount sufficient for diagnosis.

[0014] This object is achieved by a kit of parts comprising:

[0015] Biopsy instruments,

[0016] A control unit, the control unit comprising a motor,

[0017] drive lines, and

[0018] Telescopic mechanism,

[0019] Biopsy instruments include:

[0020] a base member extending from a proximal end to a distal end along a central geometric axis, wherein the distal portion of the base member is shaped as an elongated hollow tube, the elongated hollow tube at the distal end of the base member being provided with a distally facing circular cutting edge defining a mouth of the distal end of the elongated hollow tube, and the elongated hollow tube being intended to be at least partially inserted into a tissue from which a biopsy is to be obtained,

[0021] wherein the base member is capable of transmitting force along the central geometric axis so that movement of the proximal end of the base member along the central geometric axis is transmitted into movement of the distal end of the base member along the central geometric axis, and the base member is capable of transmitting torque around the central geometric axis so that rotation and torque around the central geometric axis applied by the motor at the proximal end of the base member are transmitted from the proximal end of the base member to the distal end of the base member, thereby causing the distal end of the base member to rotate around the central geometric axis,

[0022] wherein the telescopic mechanism is configured to be connected to a proximal end of a biopsy instrument or to form a proximal part of the biopsy instrument,

[0023] The telescopic mechanism is configured to be connected to the manipulation unit via a drive line, so that the proximal end of the base member is configured to be connected to a motor, so that rotation and torque can be applied to the proximal end of the base member by the motor and transmitted by the base member to the elongated hollow tube at the distal end of the base member.

[0024] The advantage of this set of parts compared to the biopsy instruments of the prior art is that the biopsy instrument can retrieve a tissue sample of an amount sufficient for diagnosis in a relatively short time. The set of parts can also be referred to as a biopsy instrument or instrument. In such a case, the above-mentioned parts mentioned as a biopsy instrument can be, for example, referred to as disposable parts of a biopsy instrument. The set of parts can also be referred to as a biopsy system or method. The instrument can directly retrieve multiple tissue samples one by one without the need to harvest previous samples.

[0025] It can also be noted that the instrument can retrieve tissue samples without having to apply any negative pressure. In fact, for most applications, the instrument is envisioned to be used without applying any negative pressure.

[0026] When a biopsy is to be obtained, the cutting edge and the distal end of the elongated hollow tube are configured to be advanced into the tissue along the central geometric axis while being rotated by a motor at its proximal end, and thereby cut the core of the tissue, the core of the tissue passing through the mouth relative to the elongated hollow tube due to the advancement of the elongated hollow tube into the sample acquisition portion of the elongated hollow tube, wherein the circumferential outer surface of the core at least partially abuts the smooth inner surface of the sample acquisition portion, thereafter, the elongated hollow tube is retracted from the tissue while being rotated by a motor at its proximal end, whereby the core of the tissue is detached from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by an adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, the adhesion force holding the core in the sample acquisition portion having a smooth inner surface.

[0027] As the distal end is advanced into the tissue a second time, the first sample is pushed further into the hollow tube toward the proximal end by the core of the second sample in a controlled manner. This allows the physician to retain any information provided by the body layer and / or location of the corresponding sample, which in turn can be used to increase the amount of data provided by the biopsy, which in turn can improve the accuracy of the diagnosis ultimately provided.

[0028] The telescoping mechanism can provide an adjustable length along the axis. Such telescoping function can be used to advance and retract the elongated hollow tube mentioned above. The telescoping mechanism can also provide one or more limitations on the maximum extension of the distal end of the elongated hollow tubular member, for example.

[0029] The telescopic mechanism may also be provided with one or more locking members, by means of which the components of the telescopic mechanism may be locked relative to each other.

[0030] The telescoping feature may also be used to allow a biopsy instrument of a certain length to be used in different types of endoscopes having working channels of slightly different lengths as measured between the entry opening and the distal opening.

[0031] Furthermore, by connecting the steering unit with the motor to the telescopic mechanism via a drive line, the steering unit can be provided as a separate box located on a shelf or cart or the like in the examination room. Thus, the weight of the steering unit becomes somewhat less important. This can be exploited, for example, to use relatively powerful motors, to provide relatively complex electronic circuits, to provide a connection to a power source, to provide a battery backup, etc.

[0032] The base member is flexible from a bending perspective, whereby the biopsy instrument can extend along a central geometric axis, have different shapes and time-varying shapes, as is typically required for biopsy instruments used in endoscopes.

[0033] It can be noted that it is also conceivable to provide a removable inner member that is configured to be positioned within the base member and that is configured to close the opening of the hollow tube at the distal end of the base member during insertion of the biopsy instrument, thereby preventing tissue from being unnecessarily filled into the hollow tube. The removable inner member can also be configured to close the distal opening of the outer elongated hollow member during insertion of the biopsy instrument, thereby preventing tissue from being unnecessarily filled into the outer elongated hollow member.

[0034] It can be noted that the direction of rotation during advancement and during retraction can be the same, but not necessarily the same. For example, it is advantageous to have the same direction of rotation, for example, when the ability of the base member to transmit torque in one direction of rotation is stronger than its ability to transmit torque in the opposite direction of rotation. This difference in torque transmission ability may occur when, for example, the base member is designed as a wire, such as a cord or a hollow cord. In one direction of rotation, the winding of the wire has a tendency to tighten, and when the transmitted torque has a tendency to tighten the winding, the wire is usually relatively strong. From the user's perspective, it is advantageous if the rotation is maintained in the same direction of rotation during the elongated hollow tube of the base member is advanced into the tissue and during the elongated hollow tube of the base member is retracted outside the tissue, and preferably also the same or at least similar rotation speed is maintained, because any tactile feedback from the tissue to the user via the instrument will typically be caused by the tissue, and will not be affected by the difference in the specific interaction between the tissue and the elongated hollow tube for different directions of rotation and / or rotation speeds.

[0035] The motor can be configured to provide rotation of the elongated hollow tube about the central geometric axis by applying rotation and torque to the proximal end of the base member at a certain rotational speed as the elongated hollow tube is advanced and retracted, the rotational speed being at least 13,000 rpm, preferably between 13,000 rpm and 25,000 rpm, and more preferably between 13,000 rpm and 20,000 rpm.

[0036] Providing a rotational speed of at least 13000 rpm is particularly useful for a design that is flexible from a bending perspective for a base member, because a relatively high rotational speed will allow a relatively blunt cutting edge to effectively penetrate tissue, and because the rotation of the base member will stabilize the components at the distal end of the base member. The fact that a relatively blunt cutting edge can be provided is advantageous because it reduces the risk of the cutting edge getting stuck in an endoscope or in an optional outer elongated hollow tubular member, particularly when the endoscope or the optional outer elongated hollow tubular member is flexible and is bent more sharply. Preferably, the cutting edge is a blunt cutting edge. The fact that a relatively blunt cutting edge can be provided is advantageous because it reduces the risk of the cutting edge accidentally cutting tissue before starting rotation. According to a preferred embodiment, the rotational speed can be between 13000 rpm and 25000 rpm. The upper limit depends in particular on mechanical constraints. In some embodiments, a higher upper limit, such as 30000 rpm, may be possible. In addition, in the embodiments described herein, there is currently no improvement obtained by a higher rotational speed, but an improvement can be obtained in other designs or embodiments of the present invention. According to a more preferred embodiment, the rotation speed is between 13000 rpm and 20000 rpm. It can be noted that in order to achieve the desired cutting effect, the rotation speed relative to the tissue is at least 13000 rpm. However, from a practical point of view, since the optional outer elongated hollow tubular member will be connected to the housing of the steering unit, and the base member is connected to the motor, the rotation speed of the base member relative to the optional outer elongated hollow tubular member is also at least 13000 rpm.

[0037] The telescopic mechanism may be provided with a connector at its distal end, by which the telescopic mechanism is constructed to be fixedly connected to the insertion opening of the endoscope, wherein the connector is preferably rotatable relative to the telescopic mechanism around a central geometric axis, whereby the telescopic mechanism can rotate relative to the insertion opening of the endoscope around the central geometric axis.

[0038] By having such a connector, allowing the rest of the telescopic mechanism to rotate relative to the connector about the central axis, the physician will find it easier to find a comfortable working position in which the functions of the telescopic function can be manipulated as intended. This in turn will reduce the risk of the patient suffering any discomfort. It can be noted that this rotatability is provided to allow the physician to find a working position, and not to allow the telescopic mechanism to be rotated by the motor. The rotation of the motor is transmitted internally within the telescopic mechanism, independently of the fact that the handle formed by the telescopic mechanism can be rotated about the connector.

[0039] The telescoping mechanism may be provided with a connector at its proximal end, by which the connector of the drive line is connected to the telescoping mechanism, wherein the connector of the telescoping mechanism and / or the connector of the drive line is provided with a locking mechanism, wherein the locking mechanism allows the connectors to be connected to each other only by relative movement toward each other along the central axis, but prevents the connectors from being disconnected by relative movement away from each other until the locking mechanism has been released.

[0040] This is advantageous as it will allow the physician to position the endoscope and biopsy instrument at the desired location and thereafter, the drive wire can be easily connected just prior to the sampling time by simply moving the drive wire towards the telescoping mechanism. Furthermore, since the connection is not easily disconnected, the risk of unintentional disconnection is minimized. In this context, it may be noted that merely is intended to mean that only relative movement is required to achieve the mutual connection without any necessity for any manipulation of the locking mechanism. The relative movement may be a purely translational movement or may be a combined rotational and translational movement.

[0041] This type of locking mechanism typically includes: one of the connectors (i.e., the first connector), the first connector includes a movable member or part, which is movable in a direction having a component transverse to the central axis and is elastically biased to contact with another connector (the second connector). The front end of the movable member or part and the end facing the second connector, and / or the front end of the second connector are typically shaped as a chamfer or fillet or the like, so that the movement of the second connector toward the connection position will cause the chamfer to act as a cam and move the movable member or part laterally until the step or shoulder or the like of the second connector has passed through the movable member or part. The rear end of the movable member or part and the rear end of the step or shoulder are typically shaped so that the surface extends laterally, so that they will not act as a cam in the same way as the front end. Therefore, the physician needs to release the locking mechanism before the connector can be disconnected. For example, this can be achieved by connecting the movable member or part to a button or lever, by which the physician can move the movable member or part in the same direction as the cam action. The locking mechanism can, for example, be a so-called cut-off locking mechanism. In a preferred embodiment, the movable member or part of the locking mechanism and also the release mechanism are arranged on the connector of the drive line. As mentioned above, the locking mechanism can be combined with a purely translational movement, or with a system providing a threaded or cam mechanism, via which the mutual connection is provided by a combined rotational and translational movement. For example, the latter can be of the type known as a bayonet connection. It can also be noted that in a connection where there is such a combined rotational and translational movement, it is conceivable to omit the locking mechanism and rely solely on internal friction to keep the parts in the mutually connected state.

[0042] The steering unit may be provided with a connector via which rotation and torque from the motor may be applied to the drive wire by the drive wire having a connector at its proximal end, the connector of the drive wire being configured to connect to a connector of the steering unit, wherein the connector of the steering unit and / or the connector of the drive wire having a locking mechanism, wherein the locking mechanism allows the connectors to be connected to each other only by relative movement towards each other along a central axis, but prevents the connectors from being disconnected by relative movement away from each other until the locking mechanism has been released. This may be, for example, of a different type as discussed with reference to the connection between the telescopic mechanism and the drive wire. In a preferred embodiment, a movable member or part of the locking mechanism and also a release mechanism are provided for the connection on the connector of the drive wire.

[0043] The outer surface (39d) of the drive wire (39) can be formed by a polymer-based material or a flexible coating, wherein the polymer-based material is preferably an elastomeric material or a plastic material, wherein the polymer-based material or the flexible coating forms a low-friction and non-adhesive surface. The flexible coating can be a polymer-based material. The low-friction and non-adhesive surface can be referred to as a smooth surface. When the surface is treated to provide a non-sticky or non-adhesive surface, the surface should preferably be at least as smooth as silicone rubber. Preferably, the surface has a smoothness close to that of a plastic material (such as polyethylene), or more preferably a smoothness comparable to or even smoother than HDPE. It can be noted that this smoothness is preferably also related to the fact that the surface should be made as a flat surface, at least flat along the longitudinal extension of the drive wire. This reduces the risk of the drive wire being accidentally entangled in the physician's clothes. If the drive wire is entangled in the physician's clothes, any movement of the physician may be accidentally converted into movement of the biopsy instrument, which increases the risk.

[0044] The inner or outer surface of the sample acquisition portion may be liquid-impermeable, wherein preferably the entire length of the inner or outer surface of the base member is liquid-impermeable.

[0045] The inner or outer surface of the sample acquisition part is preferably liquid-tight. During the period when the elongated hollow tube is retracted outside the tissue, when adhesion is formed between the outer envelope surface of the tissue core, this is beneficial. When subjected to tension, the change of tissue geometry will locally cause local negative pressure in a sense to enhance adhesion. If the elongated hollow tube is closed at the proximal end or is subjected to negative pressure at the proximal end, the situation of this local negative pressure is particularly obvious. Preferably, the inner or outer surface of the sample acquisition part is also gas-tight. It can be noted that the preferred properties of the inner or outer surface are liquid-tight, and more preferably still gas-tight, which does not necessarily mean that when it comes to long-term performance, the inner or outer surface needs to be liquid-tight and gas-tight. The preferred properties of the inner or outer surface are liquid-tight, which actually means that the surface is preferably at least in a time period sufficient to retrieve the biopsy sample, and preferably also in a time period sufficient to allow the sample to be harvested. It is liquid-tight. That is, the inner or outer surface should preferably be liquid-tight at least in several seconds. Similarly, it is preferred that either the inner or outer surface is also gas impermeable, at least for a period of time sufficient to retrieve a biopsy sample, and preferably also for a period of time sufficient to allow the sample to be harvested.

[0046] In a preferred embodiment, the inner surface is impermeable to liquids, and more preferably also impermeable to gases. It can be noted that the smooth inner surface is preferably impermeable to liquids, and more preferably also impermeable to gases.

[0047] The elongated hollow tube may have a hollow elongated tubular sample acquisition portion at a distal portion of the elongated hollow tube, the hollow elongated tubular sample acquisition portion having a smooth inner surface.

[0048] Preferably, the hollow tube has an extension, i.e. a length segment along the central geometric axis, and is provided with said smooth surface along the length from the distal end toward the proximal end, the extension having a length at least allowing one after another to acquire at least two, preferably at least three reference samples of the above disclosed type.

[0049] It can be noted that in the above, it is mentioned that a reference sample is used. When defining the reference of smoothness, the concept of referring to a reference sample is used, because the biopsy instrument can be used according to many different methods in actual biopsy sampling. The biopsy instrument can be used, for example, according to a method in which the reference is as described above and, for example, as Figures 3a to 5 As shown, the biopsy instrument is actually used, that is, the distal end is advanced into the tissue for a distance and then retracted. However, according to another method, the biopsy instrument can be used to move along the surface of the tissue from which the biopsy is to be obtained, such as Figures 13a to 13c and Figures 14a to 14c As shown. Figure 3a to Figure 3b and Figure 4In the user method shown, the distal end is fully inserted into the tissue, that is, the distal end is inserted in a manner that the entire circumference is inserted into the tissue, thereby forming an adhesion force greater than the breaking force required to detach the core from the tissue. Figures 13a to 13c and Figures 14a to 14c In the method shown, the distal end is only partially inserted into the tissue, that is, the distal end is inserted in such a way that only a portion of the entire circumference is inserted into the tissue. The smoothness of the surface has advantages in both methods, but when performing the above-mentioned reference sample, it is clearly evident by the detachment of the core from the rest of the tissue and the adhesion provided by the smoothness can be observed. It can be noted that the reference sample refers to a sample performed in healthy tissue.

[0050] The distally facing circular cutting edge may be shaped and a smooth inner surface (preferably a liquid-impermeable smooth inner surface) may be connected to the cutting edge such that the smooth inner surface extends to a distal-most portion of the cutting edge as viewed along the central geometric axis.

[0051] The fact that the smooth inner surface is connected to the cutting edge such that the smooth inner surface, seen along the central geometric axis, extends to the most distal portion of the cutting edge provides adhesion between the smooth inner surface and the circumferential outer surface of the core up to the incision in the tissue, seen along the central geometric axis. This is advantageous when it comes to achieving a clear and effective separation between the core of tissue captured inside the elongated hollow tube and the remaining portion of the tissue just outside the mouth of the sample acquisition portion of the elongated hollow tube. This is further enhanced if the smooth inner surface is a liquid-impermeable smooth inner surface connected to the cutting edge such that the liquid-impermeable smooth inner surface extends to the most distal portion of the cutting edge, seen along the central geometric axis.

[0052] The smoothness of the smooth inner surface is such that when a reference biopsy is to be obtained, the cutting edge and the distal end of the elongated hollow tube are configured to be advanced into the tissue along the central geometric axis while being driven by a motor at its proximal end to rotate at a rotational speed of at least 13,000 rpm, and thereby cut the core of the tissue, the core of the tissue passing through the mouth relative to the elongated hollow tube due to the advancement of the elongated hollow tube into the sample acquisition portion of the elongated hollow tube, wherein the circumferential outer surface of the core at least partially abuts the smooth inner surface of the sample acquisition portion, thereafter, the hollow tube is retracted from the tissue while being driven by a motor at its proximal end to rotate at a rotational speed of at least 13,000 rpm, whereby the core of the tissue is detached from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by an adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, the adhesion force holding the core in the sample acquisition portion having a smooth inner surface.

[0053] Preferably, the smoothness of the surface is such that when the reference sample is performed using the above-mentioned type of biopsy instrument, the core is detached from the tissue during the retraction of the elongated hollow tube when the distance at which the distal end has been inserted into the tissue is equal to or greater than the inner diameter of the mouth. However, in many cases, it is preferred that the smoothness of the surface is such that when the reference sample is performed using the above-mentioned type of biopsy instrument, the core is detached from the tissue during the retraction of the hollow tube when the distance at which the distal end has been inserted into the tissue is 1.3 times or more of the inner diameter of the mouth. However, in many cases, it is more preferred that the smoothness of the surface is such that when the reference sample is performed using the above-mentioned type of biopsy instrument, the core is detached from the tissue during the retraction of the hollow tube when the distance at which the distal end has been inserted into the tissue is at least 1.7 times or more of the inner diameter of the mouth. The above is at least applicable to inner diameters between 1 mm and 5 mm. However, it can be noted that the above is a reference sample, and in practice it is conceivable to use a smaller inner diameter, such as about 0.75 mm or even a smaller inner diameter, such as about 0.5 mm. Therefore, the inner diameter can be, for example, between 0.5 mm and 5 mm.

[0054] When the smooth inner surface is formed of steel such as medical grade stainless steel, the surface roughness Ra value of the smooth inner surface can be less than 1.5 µm, preferably less than 1 µm, and when the smooth inner surface is formed of a polymer-based material, the surface roughness Ra value of the smooth inner surface is less than 6 µm, such as between 1 µm and 6 µm.

[0055] The smooth inner surface may be formed from a polymer-based material.

[0056] The biopsy instrument may further include:

[0057] an outer elongated hollow tubular member extending from a proximal end along a central geometric axis to a distal end,

[0058] wherein the base member is disposed within the outer elongated hollow tubular member and independently rotationally and translationally moves relative to the outer elongated hollow tubular member,

[0059] The elongated hollow tube can be advanced to the outside of the distal end of the outer elongated hollow tubular member and retracted into the outer elongated hollow tubular member by moving the proximal end of the base member along the central geometric axis, and at the same time, rotation and torque are applied by a motor at the proximal end of the base member, so that the elongated hollow tube can rotate around the central geometric axis within and relative to the outer elongated hollow tubular member.

[0060] This design allows the physician to advance the distal end of the biopsy instrument beyond the distal end of the endoscope and still have an outer member that does not rotate and an inner member that can be independently advanced and rotated relative thereto to retrieve a tissue sample. It also reduces any wear on the working channel of the endoscope.

[0061] It can be noted that the outer elongated hollow tubular member is typically connected to a component of the manipulation unit other than the motor, so that the base member can be rotated relative to the outer elongated hollow tubular member by the motor. The outer elongated hollow tubular member can be connected to the housing or connected to the housing via a telescopic mechanism, for example. The telescopic mechanism allows the outer elongated hollow tubular member to move translationally relative to the housing within the boundaries defined by the telescopic mechanism. It can be noted that the telescopic mechanism can allow the outer elongated hollow tubular member to rotate relative to the housing, such as by hand, allowing the angular orientation of the outer elongated hollow tubular member to be adjusted. For example, along the circumference of the outer elongated hollow tubular member, if the distal end of the outer elongated hollow tubular member is provided with a stopper having a variable shape, such adjustment may be required. However, the proximal end of the outer elongated hollow tubular member is connected to the manipulation unit so that it is at least semi-stationary relative to the housing, that is, so that it is not rotated relative to the housing by any motor. Advantageously, the outer elongate hollow tubular member is stationary relative to the tissue so that it does not accidentally damage the tissue, which could otherwise easily occur if the outer elongate hollow tubular member were rotated at high speed relative to the tissue. In this context, it may be noted that advantageously, the instrument allows the elongate hollow tube of the base member to be rotated at a high rotational speed before the elongate hollow tube of the base member is advanced out of the outer elongate hollow tubular member, while the elongate hollow tube of the base member is advanced into the tissue, and also while the elongate hollow tube of the base member is retracted into the outer elongate hollow tubular member.

[0062] One or more limits of the telescoping mechanism may be used, for example, to provide a maximum extension of the distal end of the elongated hollow tubular member beyond the outer elongated hollow tubular member and / or to provide a maximum extension of the distal end of the outer elongated hollow tubular member, such as relative to an endoscope.

[0063] The motor can be configured to provide rotation of the elongated hollow tube about a central geometric axis within and relative to the outer elongated hollow tubular member by applying rotation and torque to the proximal end of the base member at a certain rotational speed when the elongated hollow tube is advanced beyond the distal end of the outer elongated hollow tubular member and retracted into the outer elongated hollow tubular member, the base member is preferably flexible and the outer elongated hollow tubular member is preferably flexible, and the rotational speed is preferably at least 13,000 rpm, preferably between 13,000 and 25,000 rpm, and more preferably between 13,000 and 20,000 rpm.

[0064] In this context it may be noted that features of some preferred embodiments are discussed below with reference to a biopsy instrument comprising an elongated hollow tubular member, although the above-described kit of parts need not include an elongated hollow tubular member, the advantages discussed below with reference to various preferred embodiments also relate to the preferred embodiments of the above-described kit of parts, as well as to those embodiments that do not include an elongated hollow tubular member.

[0065] The base member may include an inner elongate hollow tubular member extending from a proximal end to a distal end of the base member.

[0066] The polymer-based material forming the smooth inner surface may be provided as a film, preferably a tubular film, which is inserted into the inner elongated hollow tubular member and attached to the inner side surface of the inner elongated hollow tubular member.

[0067] The inner elongated hollow tubular member may include a hollow metal wire rope, which is capable of transmitting force along the central geometric axis so that movement of the proximal end along the central geometric axis is transmitted as movement of the distal end along the central geometric axis, and the hollow metal wire rope is capable of transmitting torque around the central geometric axis so that rotation and torque around the central geometric axis applied by the motor at the proximal end are transmitted from the proximal end to the distal end, thereby causing the distal end to rotate around the central geometric axis.

[0068] The inner elongated hollow tubular member is provided with the distally facing circular cutting edge at its distal end.

[0069] The outer elongate hollow tubular member may comprise a hollow metal wire.

[0070] The base member preferably comprises an inner elongate hollow tubular member, which may be provided at its proximal end with a connector for connection, preferably releasable connection, to a motor, the connector being capable of transmitting said movement along the central geometric axis as well as said rotation and torque.

[0071] The core may be separated from the tissue by shear forces and / or tensile forces.

[0072] The above object is also achieved by a biopsy instrument, which comprises:

[0073] a base member extending from a proximal end to a distal end along a central geometric axis, wherein at least the distal portion of the base member is shaped as an elongated hollow tube, the elongated hollow tube at the distal end of the base member being provided with a distally facing circular cutting edge, the distally facing circular cutting edge defining a mouth at the distal end of the elongated hollow tube, and the elongated hollow tube being intended to be at least partially inserted into a tissue from which a biopsy is to be obtained,

[0074] wherein the base member is capable of transmitting force along the central geometric axis so that movement of the proximal end of the base member along the central geometric axis is transmitted into movement of the distal end of the base member along the central geometric axis, and the base member is capable of transmitting torque around the central geometric axis so that rotation and torque around the central geometric axis applied by the motor at the proximal end of the base member are transmitted from the proximal end of the base member to the distal end of the base member, thereby causing the distal end of the base member to rotate around the central geometric axis,

[0075] wherein the proximal end of the base member is configured to be connected to a motor, preferably via a telescoping mechanism, the telescoping mechanism being configured to be connected to the proximal end of the biopsy instrument or formed as a proximal part of the biopsy instrument, so that rotation and torque can be applied by the motor to the proximal end of the base member and transmitted by the base member to the elongated hollow tube at the distal end of the base member,

[0076] wherein the motor is configured to provide rotation of the elongated hollow tube about the central geometric axis within and relative to the outer elongated hollow tubular member by applying rotation and torque to the proximal end of the base member as the elongated hollow tube is advanced beyond the distal end of the outer elongated hollow tubular member and retracted into the outer elongated hollow tubular member,

[0077] Wherein when the smooth inner surface is formed of steel such as medical grade stainless steel, the surface roughness Ra value of the smooth inner surface is less than 1.5 µm, preferably less than 1 µm, and when the smooth inner surface is formed of a polymer-based material, the surface roughness Ra value of the smooth inner surface is less than 6 µm, such as between 1 µm and 6 µm.

[0078] The advantages discussed above with reference to the kit of parts also relate to this biopsy instrument. It can also be noted that the surface roughness value Ra is preferably determined according to standard ISO 4287:1997. Preferably, the surface has low friction. Currently, this is considered to be a reason why higher Ra values ​​are possible when the smooth inner surface is formed by a polymer-based material than when the smooth inner surface is formed by steel. Therefore, it is considered that the suitable Ra value increases with the decrease of the friction coefficient. Therefore, it is found that a suitable combination is a material with a friction coefficient of about 0.6 to 1.0, such as for steel on steel, the combined Ra value is between 0.05 μm and 1.5 μm, preferably between 0.05 μm and 1 μm, and another suitable combination is a material with a friction coefficient of about 0.02 to 0.3, such as for the polymer-based materials mentioned below, the combined Ra value is between 1 μm and 6 μm.

[0079] The above objects are also achieved by a method for obtaining a biopsy, the method comprising:

[0080] A biopsy instrument is provided, the biopsy instrument comprising:

[0081] a base member extending from a proximal end to a distal end along a central geometric axis, wherein at least the distal portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge, the distally facing circular cutting edge defining a mouth at the distal end of the hollow tube, the elongated hollow tube at the distal end being intended to be at least partially inserted into tissue from which a biopsy is to be obtained,

[0082] providing a steering unit having a motor,

[0083] connecting the proximal end of the base member to the motor, preferably via a telescoping mechanism configured to be connected to the proximal end of the biopsy instrument or to form a proximal part of the biopsy instrument,

[0084] Move the distal end of the biopsy instrument to the location where the tissue sample is to be obtained.

[0085] activating the motor so that rotation is imparted to the distal end of the biopsy instrument, preferably at a rotation speed of at least 13,000 rpm,

[0086] advancing the elongated hollow tube together with the circular cutting blade facing distally into the tissue from which the tissue sample is to be obtained, while the distal end of the base member is rotated by a motor at a rotational speed of preferably at least 13,000 rpm, thereby cutting a core of the tissue, which core of the tissue passes relative to the elongated hollow tube through the mouth into the sample acquisition portion of the elongated hollow tube due to the advancement of the elongated hollow tube,

[0087] while the distal end of the base member is rotated by the motor, retracting the distal end of the base member out of the tissue, wherein the circumferential outer surface of the core at least partially abuts against the smooth inner surface of the hollow elongated tubular sample acquisition portion disposed at the distal portion of the elongated hollow tube,

[0088] The core of tissue is thereby detached from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by adhesion forces formed at the interface between the smooth inner surface and the circumferential outer surface of the core, which retains the core within the sample acquisition portion having a smooth inner surface.

[0089] The advantages discussed above with reference to the kit of parts also apply to this method.

[0090] The above object is also achieved by a kit of parts, the kit of parts comprising:

[0091] Biopsy instruments, and

[0092] A control unit, the control unit comprising a motor,

[0093] Biopsy instruments include:

[0094] an outer elongated hollow tubular member extending from a proximal end to a distal end along a central geometric axis, and

[0095] a base member extending from a proximal end to a distal end along a central geometric axis, wherein at least the distal portion of the base member is shaped as an elongated hollow tube, the elongated hollow tube at the distal end of the base member being intended to be at least partially inserted into tissue from which a biopsy is to be obtained,

[0096] wherein the base member is disposed within the outer elongated hollow tubular member and independently rotationally and translationally moves relative to the outer elongated hollow tubular member,

[0097] wherein the base member is capable of transmitting force along the central geometric axis so that movement of the proximal end of the base member along the central geometric axis is transmitted into movement of the distal end of the base member along the central geometric axis, and the base member is capable of transmitting torque around the central geometric axis so that rotation and torque around the central geometric axis applied by the motor at the proximal end of the base member are transmitted from the proximal end of the base member to the distal end of the base member, thereby causing the distal end of the base member to rotate around the central geometric axis,

[0098] wherein by movement of the proximal end of the base member along the central geometric axis, the elongated hollow tube can be advanced beyond the distal end of the outer elongated hollow tubular member and the elongated hollow tube will be able to retract into the outer elongated hollow tubular member, while by applying rotation and torque at the proximal end of the base member by the motor, the elongated hollow tube can rotate about the central geometric axis within and relative to the outer elongated hollow tubular member,

[0099] wherein the elongated hollow tube is provided with a distally facing circular cutting edge, the distally facing circular cutting edge defining a mouth at the distal end of the elongated hollow tube, and

[0100] wherein the elongated hollow tube has a hollow elongated tubular sample acquisition portion at a distal portion of the elongated hollow tube, the hollow elongated tubular sample acquisition portion having a smooth inner surface,

[0101] wherein the proximal end of the base member is configured to be connected to a motor so that rotation and torque can be applied by the motor to the proximal end of the base member and transmitted by the base member to the elongated hollow tube at the distal end of the base member, and

[0102] Wherein the motor is configured to provide rotation of the elongated hollow tube about a central geometric axis within and relative to the outer elongated hollow tubular member by applying rotation and torque to the proximal end of the base member at a rotational speed of at least 13,000 rpm when the elongated hollow tube is advanced beyond the distal end of the outer elongated hollow tubular member and retracted into the outer elongated hollow tubular member, the base member being flexible and the outer elongated hollow tubular member being flexible.

[0103] The advantage of this set of parts compared with the biopsy instruments of the prior art is that the set of parts can retrieve a tissue sample of an amount sufficient for diagnosis in a relatively short time. The set of parts can also be referred to as a biopsy instrument or instrument. In this case, the above-mentioned parts mentioned as a biopsy instrument can be, for example, a disposable component of a biopsy instrument. The set of parts can also be referred to as a biopsy system. The instrument can directly retrieve multiple tissue samples one by one without the need to harvest previous samples.

[0104] When a biopsy is to be obtained, the cutting edge and the distal end of the elongated hollow tube are configured to be advanced into the tissue along the central geometric axis while being rotated at a rotational speed of at least 13,000 rpm by a motor at its proximal end, and thereby cut the core of the tissue, the core of the tissue passing through the mouth relative to the elongated hollow tube due to the advancement of the elongated hollow tube into the sample acquisition portion of the elongated hollow tube, wherein the circumferential outer surface of the core at least partially abuts the smooth inner surface of the sample acquisition portion, thereafter, the elongated hollow tube is retracted from the tissue while being rotated at a rotational speed of at least 13,000 rpm by a motor at its proximal end, whereby the core of the tissue is detached from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by an adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, the adhesion force holding the core in the sample acquisition portion having a smooth inner surface.

[0105] When the distal end is advanced into the tissue for the second time, the first sample is pushed further into the hollow tube towards the proximal end by the core of the second sample in a controlled manner. The fact that the hollow tube is provided with a smooth inner surface causes the core to adhere to the inside of the hollow tube due to the smooth surface and the liquid present in the tissue, which allows the sample to be retrieved with minimal damage to the sample and still allows the cutting edge and the distal end to drill into and out of the tissue, thereby reducing the discomfort of the patient. When the core adheres to the inside of the elongated tubular member, the core will be twisted at the mouth of the elongated tubular member due to shear or tensile forces and separated from the sample site. Compared with the biopsy instruments of the prior art, the biopsy instrument of the present invention does not require any hooks or the like on the inside of the instrument (the hooks have the disadvantage that they are difficult to combine with drilling into and out of the tissue), and it is more to avoid damaging the sample. The fact that the biopsy instrument of the present invention is so gentle to the sample also allows the sample to be harvested in a controlled manner, so that each sample is still uniquely identifiable and still undamaged or coherent. This allows the physician to retain any information provided by the slices and / or location of the corresponding sample, which in turn can be used to increase the amount of data provided by the biopsy, which in turn can improve the accuracy of the diagnosis ultimately provided.

[0106] It may be noted that the phrase that the base member is independently rotationally and translationally movable relative to the outer elongate hollow tubular member is intended to mean that rotational movement is independent of translational movement, and vice versa.

[0107] It can be noted that in the above, it is mentioned that a reference sample is used. When defining the reference of smoothness, the concept of referring to a reference sample is used, because the biopsy instrument can be used according to a variety of different methods in actual biopsy sampling. The biopsy instrument can be used, for example, according to a method in which the reference sample is as described above and, for example, as shown in FIG. 3 to FIG. Figure 5 As shown, the biopsy instrument is actually used by advancing the distal end into the tissue for a distance and then retracting it. However, according to another method, the biopsy instrument can be used to move along the surface of the tissue from which the biopsy is to be obtained, such as Figures 13a to 13c and Figures 14a to 14c As shown. Figure 3a to Figure 3b and Figure 4 In the user method shown, the distal end is fully inserted into the tissue, that is, the distal end is inserted in a manner that the entire circumference is inserted into the tissue, thereby forming an adhesion force greater than the breaking force required to detach the core from the tissue. Figures 13a to 13c and Figures 14a to 14c In the method shown, the distal end is only partially inserted into the tissue, that is, the distal end is inserted in such a way that only a portion of the entire circumference is inserted into the tissue. The smoothness of the surface has advantages in both methods, but when performing the above-mentioned reference sample, it is clearly evident by the detachment of the core from the rest of the tissue and the adhesion provided by the smoothness can be observed. It can be noted that the reference sample refers to a sample performed in healthy tissue.

[0108] Preferably, the hollow tube has an extension, i.e. a length segment along the central geometric axis, and the hollow tube is provided with said smooth surface along the length from the distal end toward the proximal end, the extension having a length that at least allows acquiring at least two, preferably at least three reference samples of the above-disclosed type one after another.

[0109] From the perspective of bending, the base member and the outer elongated hollow tubular member are flexible, so that the biopsy instrument can extend along the central geometric axis with various and time-varying shapes, which is typically required for the biopsy instrument in the endoscope. This flexible biopsy instrument for endoscopes is sometimes referred to as an endoscopic biopsy instrument. For the design that the base member and the outer elongated hollow tubular member are flexible (from the perspective of bending), it is particularly useful to provide a rotation speed of at least 13000 rpm, because the relatively high rotation speed will allow the relatively blunt cutting edge to effectively penetrate the tissue, and because the rotation of the base member will stabilize the parts extending outside the outer elongated hollow tubular member at the distal end of the base member. The fact that a relatively blunt cutting edge can be provided is advantageous because it reduces the risk of the cutting edge being stuck in the outer elongated hollow tubular member, particularly when the outer elongated hollow tubular member is flexible and is bent more sharply. Preferably, the cutting edge is a blunt cutting edge. The fact that a relatively blunt cutting edge can be provided is advantageous because it reduces the risk of the cutting edge accidentally cutting tissue before the rotation is started. According to a preferred embodiment, the rotational speed can be between 13000 rpm and 25000 rpm. The upper limit depends, among other things, on mechanical constraints. In some embodiments, a higher upper limit, such as 30000 rpm, may be possible. In addition, in the embodiments described herein, no improved effect is currently obtained by a higher rotational speed, but an improved effect may be achieved in other designs or embodiments of the present invention. According to a more preferred embodiment, the rotational speed is between 13000 rpm and 20000 rpm. It may be noted that in order to achieve the desired cutting effect, the rotational speed relative to the tissue is at least 13000 rpm. However, from a practical point of view, since the outer elongated hollow tubular member is connected to the housing of the manipulation unit and the base member is connected to the motor, the rotational speed of the base member relative to the outer elongated hollow tubular member is also at least 13000 rpm.

[0110] It may be noted that, according to an alternative, the base member and the outer elongated hollow tubular member may be rigid and extend with the central geometric axis extending in a straight line, from a curved perspective. Such a rigid instrument is typically used as a stand-alone biopsy instrument. Therefore, it is typically not used in conjunction with an endoscope. Figure 23 to Figure 25 and Figures 26a to 26b An example of such an instrument is shown. In this context it may be noted that for such an instrument it is conceivable to use lower rotational speeds than those used for flexible instruments. Thus, the base member and the outer elongated hollow tubular member may be rigid and the motor designed to provide a rotational speed of at least 3000 rpm.

[0111] It can be noted that the outer elongated hollow tubular member is connected to a component of the manipulation unit other than the motor, so that the base member can be rotated relative to the outer elongated hollow tubular member by the motor. The outer elongated hollow tubular member can, for example, be connected to the housing or connected to the housing via a telescopic mechanism. The telescopic mechanism allows the outer elongated hollow tubular member to move translationally relative to the housing within the boundaries defined by the telescopic mechanism. It can be noted that the telescopic mechanism can allow the outer elongated hollow tubular member to rotate relative to the housing, for example by hand, allowing the angular orientation of the outer elongated hollow tubular member to be adjusted. For example, along the circumference of the outer elongated hollow tubular member, if the distal end of the outer elongated hollow tubular member is provided with a stopper having a variable shape, such adjustment may be required. However, the proximal end of the outer elongated hollow tubular member is connected to the manipulation unit so that it is at least semi-stationary relative to the housing, that is, so that it is not rotated relative to the housing by any motor. Advantageously, the outer elongated hollow tubular member is stationary relative to the tissue so that it does not accidentally damage the tissue, which otherwise may easily occur if the outer elongated hollow tubular member rotates at a high speed relative to the tissue. In this context, it can be noted that advantageously, the instrument allows the elongated hollow tube of the base member to rotate at a high rotational speed before the elongated hollow tube of the base member is advanced outside the outer elongated hollow tubular member, when the elongated hollow tube of the base member is advanced into the tissue, and also when the elongated hollow tube of the base member is retracted into the outer elongated hollow tubular member. It can be noted that it is conceivable to also provide a detachable inner member, which is configured to be positioned inside the base member and is configured to close the opening of the hollow tube at the distal end of the base member during the insertion of the biopsy instrument, thereby preventing the tissue from being unnecessarily filled into the hollow tube. The detachable inner member can also be configured to close the distal opening of the outer elongated hollow member during the insertion of the biopsy instrument, thereby preventing the tissue from being unnecessarily filled into the outer elongated hollow member.

[0112] It can be noted that the direction of rotation during advancement and retraction can be the same, but not necessarily the same. For example, it is advantageous to have the same direction of rotation, such as when the base member has a stronger ability to transmit torque in one direction of rotation than when it transmits torque in the opposite direction of rotation. This difference in torque transmission ability may occur when, for example, the base member is designed as a wire such as a cord or a hollow cord. In one direction of rotation, the winding of the wire has a tendency to tighten, and typically when the transmitted torque has a tendency to tighten the winding, the wire is relatively strong. From the user's perspective, it is advantageous if the elongated hollow tube of the base member is advanced into the tissue and during the elongated hollow tube of the base member is retracted outside the tissue, the rotation is maintained in the same direction of rotation, and preferably also the same or at least similar rotation speed is maintained, because any tactile feedback from the tissue to the user via the instrument is typically caused by the tissue, and will not be affected by the difference in the specific interaction between the tissue and the elongated hollow tube for different directions of rotation and / or rotation speeds.

[0113] The inner or outer surface of the sample acquisition part is preferably liquid-tight. During the elongated hollow tube retracted outside the tissue, when it comes to forming adhesion between the outer envelope surface of the tissue core, this liquid-tight is advantageous. When subjected to tension, the change of tissue geometry will locally cause local negative pressure in a sense, thereby enhancing adhesion. If the elongated hollow tube is closed at the proximal end or is subjected to negative pressure at the proximal end, the situation of this local negative pressure is particularly obvious. Preferably, the inner or outer surface of the sample acquisition part is also gas-tight. It can be noted that the preferred properties of the inner or outer surface are liquid-tight, and more preferably still gas-tight, which does not necessarily mean that when it comes to long-term performance, the inner or outer surface needs to be liquid-tight and gas-tight. The preferred properties of the inner or outer surface are liquid-tight, which actually means that the surface is preferably at least sufficient to retrieve the biopsy sample, and preferably also sufficient to allow the sample to be harvested in a time period that is liquid-tight. That is to say, the inner or outer surface should preferably be liquid-tight in at least several seconds. Similarly, it is preferred that either the inner or outer surface is also gas impermeable for at least a period of time sufficient to retrieve a biopsy sample, and preferably also sufficient to allow the sample to be harvested.

[0114] In a preferred embodiment, the inner surface is impermeable to liquids, and more preferably also impermeable to gases. It can be noted that the smooth inner surface is preferably impermeable to liquids, and more preferably also impermeable to gases.

[0115] According to a preferred embodiment, the distally facing circular cutting edge is shaped and a smooth inner surface (preferably a liquid-impermeable smooth inner surface) is connected to the cutting edge so that the smooth inner surface (preferably a liquid-impermeable smooth inner surface) extends to the most distal part of the cutting edge as seen along the central geometric axis. The fact that the smooth inner surface is connected to the cutting edge so that the smooth inner surface, as seen along the central geometric axis, extends to the most distal part of the cutting edge provides adhesion between the smooth inner surface and the circumferential outer surface of the core up to the incision in the tissue as seen along the central geometric axis. This is advantageous when it comes to achieving a clear and effective separation between the core of the tissue captured inside the elongated hollow tube and the remaining part of the tissue just outside the mouth of the sample acquisition portion of the elongated hollow tube. This is further enhanced if the smooth inner surface is a liquid-impermeable smooth inner surface connected to the cutting edge so that the liquid-impermeable smooth inner surface extends to the most distal part of the cutting edge as seen along the central geometric axis.

[0116] Preferably, the smooth inner surface is so smooth that when a reference biopsy is to be obtained, the cutting edge and the distal end of the elongated hollow tube are configured to be advanced into the tissue along the central geometric axis while being driven by a motor at its proximal end to rotate at a rotational speed of at least 13,000 rpm, and thereby cut the core of the tissue, the core of the tissue passing through the mouth relative to the elongated hollow tube due to the advancement of the elongated hollow tube into the sample acquisition portion of the elongated hollow tube, wherein the circumferential outer surface of the core at least partially abuts the smooth inner surface of the sample acquisition portion, thereafter, the elongated hollow tube is retracted from the tissue while being driven by a motor at its proximal end to rotate at a rotational speed of at least 13,000 rpm, whereby the core of the tissue is detached from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by an adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, the adhesion force holding the core inside the sample acquisition portion having a smooth inner surface.

[0117] Preferably, the smoothness of the surface is such that when a reference sample is performed using a biopsy instrument of the type described above, the core detaches from the tissue during retraction of the elongated hollow tube when the distal end has been inserted into the tissue a distance equal to or greater than the inner diameter of the mouth. However, in many cases it is preferred that the smoothness of the surface is such that when a reference sample is performed using a biopsy instrument of the type described above, the core detaches from the tissue during retraction of the hollow tube when the distal end has been inserted into the tissue a distance 1.3 times or more of the inner diameter of the mouth. However, it is more preferred that the smoothness of the surface is such that when a reference sample is performed using a biopsy instrument of the type described above, the core detaches from the tissue during retraction of the hollow tube when the distal end has been inserted into the tissue a distance at least 1.7 times or more of the inner diameter of the mouth. The above is applicable at least for inner diameters between 1 mm and 5 mm.

[0118] When the smooth inner surface is formed by steel such as medical grade stainless steel, the surface roughness Ra value of the smooth inner surface is preferably less than 1.5 μm, preferably less than 1 μm, and when the smooth inner surface is formed by a polymer-based material, the Ra value is less than 6 μm, such as between 1 μm and 6 μm. When the smooth inner surface is formed by steel such as medical grade stainless steel, the surface roughness Ra value of the smooth inner surface is preferably between 0.05 μm and 1.5 μm, preferably between 0.05 μm and 1 μm. The surface roughness value Ra is preferably determined according to standard ISO 4287:1997. Preferably, the surface has low friction. At present, this is considered to be a reason why the smooth inner surface can have a higher Ra value when it is formed by a polymer-based material than when the smooth inner surface is formed by steel. Therefore, it is considered that the appropriate Ra value increases with the decrease of the friction coefficient. Thus, one suitable combination was found to be materials with a friction coefficient of about 0.6 to 1.0, such as for steel against steel, with a combined Ra value between 0.05 µm and 1.5 µm, preferably between 0.05 µm and 1 µm, and another suitable combination was materials with a friction coefficient of about 0.02 to 0.3, such as for the polymer-based materials mentioned below, with a combined Ra value between 1 µm and 6 µm.

[0119] The smooth surface is arranged inside a tubular member such as an elongated hollow tube, the tubular member having parallel and straight generatrixes and a circular cross section. The smooth surface is arranged without protrusions. The smooth surface is arranged to cover the entire inner circumference of the tubular member. The smooth surface is arranged at least at the distal end of the tubular member.

[0120] The tubular member may also have an outer surface at least on a distal portion of the tubular member having a predetermined smoothness.

[0121] The smooth surface may be the inner surface of the tubular member. The inner surface of the tubular member may be machined to a predetermined smoothness. The inner surface may be medical grade stainless steel.

[0122] The smooth surface may be a layer or film disposed on the inner surface of the tubular member.

[0123] The smooth surface is arranged along the tubular member, and the arrangement length corresponds to at least the sample to be obtained. The length of the sample can be several millimeters to about 50 millimeters. The smooth surface can be arranged along the tubular member, and the arrangement length corresponds to a number of continuous samples to be obtained sequentially. The smooth surface can extend to the cutting edge, or end at a short distance from the cutting edge, such as 0.5 mm from the cutting edge.

[0124] For example, it is conceivable to form a base member so that the base member includes an end tube (such as a rigid end tube) at its distal end, the end tube is formed by steel processing so that the inner side of the end tube is formed by steel, and the smoothness of the inner side of the end tube is as described above, so that the sample can be obtained, wherein the end tube is relatively short to allow the instrument to follow the bend of the endoscope. On the proximal side of the end tube, the base member is formed by a hollow wire, which is provided with a polymer-based inner layer, such as by coating the polymer on the inner side of the metal hollow wire. This provides a smooth surface to allow the sample to slide further into the base member when more samples are obtained. It can be noted that the portion formed by coating the inner side of the hollow wire on the proximal side of the end tube can result in a portion with a smooth surface, that is, it has low friction, but due to the braiding, the inner surface of the hollow wire is not a flat surface, and the Ra value of this portion will be higher than that discussed above. However, in such a design, the end tube will be smooth, preferably with an Ra value as described above, so as to provide the expected adhesion during sample acquisition. The coating can be provided, for example, by so-called dip coating.

[0125] Preferably, the smooth inner surface is formed by a polymer-based material. The polymer-based material can belong to a non-sticky polymer grade generally referred to. It is advantageous to use a polymer of a non-sticky grade because this reduces the friction between the first tissue sample and the smooth surface, and is conducive to further transporting the first tissue sample into the elongated tubular member. In addition, the surface typically considered to be non-sticky is usually smooth enough to provide the required smoothness. The polymer-based material can be, for example, ethylene tetrafluoroethylene, TFE. It is also conceivable to use other plastic materials, such as other fluoropolymers. This fluoropolymer can be, for example, polytetrafluoroethylene, PTFE, perfluoroalkoxy, PFA, fluorinated ethylene propylene, FEP, and ETFE, ethylene tetrafluoroethylene.

[0126] It can be noted that the polymer-based material can be provided in a variety of different physical designs. The polymer-based material can be provided in the form of an elongated tubular member. The polymer-based material can be attached to the inner side of the outer member. The polymer-based material can be disposed within the outer member and can move and rotate relative to the outer member. The polymer-based material can be provided as a coating within the outer member. Various physical designs will be discussed in more detail below.

[0127] The base member preferably comprises an elongated hollow tubular member, which extends from the proximal end of the base member to the distal end of the base member. The base member comprises an elongated hollow tubular member extending from the proximal end to the distal end, which helps, for example, to manufacture, because the entire length of the base member can be designed in the same manner. In addition, the base member comprises an elongated hollow tubular member extending from the proximal end to the distal end, which helps to harvest the biopsy sample, because a mechanical tool (such as a flexible metal probe (stylet)) extending from the proximal end of the biopsy instrument through the complete biopsy instrument to the distal end of the biopsy instrument can be used, so that the sample can be safely pushed out. The elongated hollow tube also allows the sample to be pushed out at the distal end to harvest using an air jet or fluid injection at the proximal end. These methods require that the elongated tube is sufficiently gas-tight or sufficiently liquid-tight, so that there is a sufficient amount of air or liquid injection to actually be able to push the sample out. Preferably, the elongated hollow tube is preferably designed to have a uniform cross section extending from the proximal end to the distal end; in addition to this, the elongated hollow tube is also provided with local irregularities in the form of specific design features at the proximal end itself and / or at the distal end itself. These local irregularities can be, for example, that the hollow tube is provided with a connector at the proximal end and / or that the hollow tube is specially designed at the distal end to provide a cutting edge or to receive a separate component that provides the cutting edge.

[0128] Preferably, the inner elongate hollow tubular member is formed from a polymer based material which provides said smooth inner surface. This is a convenient way of providing a smooth inner surface.

[0129] The polymer-based material forming the smooth inner surface is preferably provided in the form of a film, preferably a tubular film, which is inserted into the inner elongated hollow tubular member and attached to the inner surface of the inner elongated hollow tubular member. The tubular film of the polymer-based material can be attached to the inner surface of the inner elongated hollow tubular member, for example, by directly or indirectly heating the polymer-based material so that it adheres to the inner surface of the inner elongated hollow tubular member.

[0130] Alternatively, the polymer-based material forming the smooth inner surface is provided as a coating.

[0131] Preferably, the inner elongated hollow tubular member includes a hollow metal wire rope, which is capable of transmitting force along the central geometric axis so that the movement of the proximal end along the central geometric axis is transmitted as the movement of the distal end along the central geometric axis, and the hollow metal wire rope is capable of transmitting torque around the central geometric axis so that the rotation and torque around the central geometric axis applied by the motor at the proximal end are transmitted from the proximal end to the distal end, thereby causing the distal end to rotate around the central geometric axis.

[0132] Preferably, the inner elongate hollow tubular member is provided with said distally facing circular cutting edge at its distal end.

[0133] Preferably, the outer elongate hollow tubular member also comprises a hollow metal wire.

[0134] The inner elongated hollow tubular member is arranged inside the outer elongated hollow tubular member and can be moved rotationally and translationally relative to the outer elongated hollow tubular member. An advantage of this design is that the outer elongated hollow tubular member can remain stationary relative to the endoscope during sample acquisition. It is intended to advance the inner elongated hollow tubular member into the tissue while the outer elongated hollow tubular member remains outside the tissue. By positioning the distal end of the outer elongated hollow tubular member outside the tissue and by advancing the distal end of the inner elongated hollow tubular member into the tissue, it helps to have good control of the insertion depth. The fact that the outer elongated hollow tubular member can remain stationary relative to the endoscope during sample acquisition can also make it possible to provide a stop for the distal end of the outer elongated hollow tubular member, which prevents the distal end from being accidentally advanced into the tissue. In addition, by allowing the outer elongated hollow tubular member to remain stationary relative to the endoscope during sample acquisition, combined with the inner elongated hollow tubular member being rotatably and translationally movable relative to the outer elongated hollow tubular member, the outer elongated hollow tubular member can be designed to fit relatively tightly with the working channel of the endoscope. In addition, since relative movement is provided between two components of the instrument that are specifically designed and manufactured for interaction, a relatively tight fit can be provided between the inner elongated hollow tubular member and the outer elongated hollow tubular member, and sufficient play is still ensured. In addition, by being able to use a tight fit, the inner elongated hollow tubular member and the outer elongated hollow tubular member will support each other in a sense and prevent each other from collapsing, which in turn allows the use of relatively thin material thicknesses in both the outer elongated hollow tubular member and the inner elongated hollow tubular member. For a given working channel with a given internal diameter, this will in turn allow the distal end of the inner elongated hollow tubular member to have a relatively large internal diameter. Other advantages and specific design features of the second embodiment will be discussed in more detail in conjunction with the accompanying drawings in the detailed description.

[0135] Preferably, the rotational movability of the inner elongate hollow tubular member is independent of the translational movability, such that the inner elongate hollow tubular member can be rotated by the motor and moved back and forth relative to the outer elongate hollow tubular member independent of the rotational movement.

[0136] It can also be noted that in this embodiment (where the inner elongated hollow tubular member is arranged in the outer elongated hollow tubular member and is rotatably and translationally movable relative to the outer elongated hollow tubular member), the base member can be rigid according to one embodiment from a bending perspective, and can be flexible according to another embodiment. In a rigid embodiment, the base member extends with a central geometric axis extending along a straight line. Such a rigid biopsy instrument is typically used as a separate biopsy instrument. In such an embodiment, the base member can be formed as a needle with a detachable internal probe. The rigid biopsy instrument allows percutaneous access to the tumor. Typically, in such an embodiment, the outer elongated hollow tubular member is fixed, and the inner elongated hollow tubular member is rotated by a motorized handle and advanced into the tissue after the probe is withdrawn. Once the rigid internal probe is completely removed, the inner hollow tube can be drilled into a hollow space, such as the abdomen, chest, sinus or joint, and used to insert other instruments, such as a camera, an injection device for fluid or gas, or a guide wire / rod. According to another embodiment of this embodiment (wherein the inner elongated hollow tubular member is arranged within the outer elongated hollow tubular member and is rotatably and translationally movable relative to the outer elongated hollow tubular member), the base member is flexible from a bending perspective, whereby the base member can extend along the central geometric axis to have a variety of shapes, which is typically required for biopsy instruments used in endoscopes. Such flexible biopsy instruments used in endoscopes are sometimes referred to as endoscopic biopsy instruments.

[0137] The flexible inner tube can be used to insert a flexible guide wire, which is then removed to leave the guide wire in place for inserting other devices such as stents and dilatation balloons.

[0138] Preferably, the inner elongated hollow tubular member is capable of transmitting force along the central geometric axis so that movement of the proximal end along the central geometric axis is transmitted as movement of the distal end along the central geometric axis, and the inner elongated hollow tubular member is capable of transmitting torque around the central geometric axis so that rotation and torque around the central geometric axis applied by the motor at the proximal end are transmitted from the proximal end to the distal end, thereby causing the distal end to rotate around the central geometric axis.

[0139] Preferably, the inner elongate hollow tubular member has at its proximal end a connector for connection, preferably releasable connection, to a motor, the connector being capable of transmitting said movement along the central geometrical axis as well as said rotation and torque.

[0140] The above object is also achieved by a biopsy instrument, which comprises:

[0141] an outer elongated hollow tubular member extending along a central geometric axis from a proximal end to a distal end, and

[0142] a base member extending from a proximal end to a distal end along a central geometric axis, wherein at least the distal portion of the base member is shaped as an elongated hollow tube, the elongated hollow tube at the distal end of the base member being intended to be at least partially inserted into tissue from which a biopsy is to be obtained,

[0143] wherein the base member is disposed within the outer elongated hollow tubular member and is independently rotatably and translationally movable relative to the outer elongated hollow tubular member,

[0144] wherein the base member is capable of transmitting force along the central geometric axis so that movement of the proximal end of the base member along the central geometric axis is transmitted into movement of the distal end of the base member along the central geometric axis, and the base member is capable of transmitting torque around the central geometric axis so that rotation and torque around the central geometric axis applied by the motor at the proximal end of the base member are transmitted from the proximal end of the base member to the distal end of the base member, thereby causing the distal end of the base member to rotate around the central geometric axis,

[0145] wherein by movement of the proximal end of the base member along the central geometric axis, the elongated hollow tube can be advanced beyond the distal end of the outer elongated hollow tubular member and the elongated hollow tube will be able to retract into the outer elongated hollow tubular member, while by applying rotation and torque to the proximal end of the base member by the motor, the elongated hollow tube can rotate about the central geometric axis within the outer elongated hollow tubular member and relative to the outer elongated hollow tubular member,

[0146] wherein the elongated hollow tube is provided with a distally facing circular cutting edge, the distally facing circular cutting edge defining a mouth at the distal end of the elongated hollow tube,

[0147] wherein the elongated hollow tube has a hollow elongated tubular sample acquisition portion at a distal portion of the elongated hollow tube, the hollow elongated tubular sample acquisition portion having a smooth inner surface,

[0148] wherein the proximal end of the base member is configured to be connected to a motor so that rotation and torque can be applied by the motor to the proximal end of the base member and transmitted by the base member to the elongated hollow tube at the distal end of the base member,

[0149] wherein the motor is configured to provide rotation of the elongated hollow tube about the central geometric axis within and relative to the outer elongated hollow tubular member by applying rotation and torque to the proximal end of the base member as the elongated hollow tube is advanced beyond the distal end of the outer elongated hollow tubular member and as the elongated hollow tube is retracted into the outer elongated hollow tubular member,

[0150] Wherein the smooth inner surface has a surface roughness having an Ra value of less than 1.5 µm, preferably less than 1 µm when formed from steel (such as medical grade stainless steel), and an Ra value of less than 6 µm, such as between 1 µm and 6 µm when formed from a polymer-based material.

[0151] The above objects are also achieved by a method for obtaining a biopsy, the method comprising:

[0152] A biopsy instrument is provided, the biopsy instrument comprising:

[0153] an outer elongated hollow tubular member extending along a central geometric axis from a proximal end to a distal end, and

[0154] a base member extending along a central geometric axis from a proximal end to a distal end, wherein at least the distal portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge defining a mouth of the distal end of the hollow tube at the distal end, the distal end being intended to be at least partially inserted into tissue from which a biopsy is to be obtained,

[0155] wherein the base member is disposed within the outer elongated hollow tubular member and is independently rotatably and translationally movable relative to the outer elongated hollow tubular member,

[0156] providing a steering unit having a motor,

[0157] Connecting the proximal end of the base member to the motor,

[0158] connecting the proximal end of the outer elongated hollow tubular member to the manipulation unit,

[0159] The distal end of the biopsy instrument is moved to a position where a tissue sample is to be obtained, preferably, the distal end of the base member is located within the outer elongated hollow tubular member,

[0160] activating the motor so that rotation at a speed of at least 13,000 rpm is imparted to the distal end of the biopsy instrument,

[0161] advancing an elongated hollow tube having a distally facing circular cutting edge into tissue from which a tissue sample is to be obtained while a motor rotates the distal end at a rotational speed of at least 13,000 rpm to cut a core of the tissue, the core of the tissue passing through the mouth into the sample acquisition portion of the elongated hollow tube due to the advancement of the elongated hollow tube relative to the elongated hollow tube,

[0162] while the distal end of the base member is rotated by the motor, retracting the distal end of the base member out of the tissue, wherein the circumferential outer surface of the core at least partially abuts against the smooth inner surface of the hollow elongated tubular sample acquisition portion disposed at the distal portion of the elongated hollow tube,

[0163] The core of tissue is thereby detached from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by adhesion forces formed at the interface between the smooth inner surface and the circumferential outer surface of the core, which retains the core within the sample acquisition portion having a smooth inner surface.

[0164] The above object is also achieved by a kit of parts, the kit of parts comprising:

[0165] a biopsy instrument of the type disclosed in its basic configuration or in any preferred embodiment, and

[0166] a steering unit comprising a motor,

[0167] The biopsy instrument may be connected to a motor at its proximal end, such that rotation and torque may be applied to the proximal end of the base member by the motor and transmitted to the distal end of the base member.

[0168] The above objects are also achieved by a method for obtaining a biopsy, the method comprising:

[0169] Connect the proximal end of the biopsy instrument to a steering unit having a motor,

[0170] Move the distal end of the biopsy instrument to the location where the tissue sample is to be obtained.

[0171] The motor is activated so that rotation is transmitted to the distal end of the biopsy instrument.

[0172] While the distal end is rotated by the motor, the distal end is advanced into the tissue from which the tissue sample is to be obtained, the distal end being formed as an elongated hollow tube at at least the distal portion of the base member, the elongated hollow tube having a distally facing circular cutting edge defining a mouth at the distal end of the hollow tube, thereby cutting a core of the tissue, the core of the tissue passing through the mouth into the sample acquisition portion of the hollow tube due to the advancement of the hollow tube relative to the hollow tube,

[0173] When the distal end is rotated by the motor, the distal end is retracted out of the tissue, and the circumferential outer surface of the core at least partially abuts against the smooth inner surface of the hollow elongated tubular sample acquisition portion disposed at the distal portion of the hollow tube,

[0174] The core of the tissue is thereby detached from the tissue by a pulling force caused by the retraction of the hollow tube and by adhesion forces formed at the interface between the smooth inner surface and the circumferential outer surface of the core, which maintains the core within the sample acquisition portion having a smooth inner surface.

[0175] The above object is also achieved by a biopsy instrument, which comprises:

[0176] a base member extending along a central geometric axis from a proximal end to a distal end, wherein at least the distal end portion of the base member is shaped as an elongated hollow tube, the distal end being intended to be at least partially inserted into tissue from which a biopsy is to be obtained,

[0177] wherein the base member may be capable of transmitting force along the central geometric axis such that movement of the proximal end along the central geometric axis is transmitted to movement of the distal end along the central geometric axis, and the base member may be capable of transmitting torque about the central geometric axis such that rotation and torque about the central geometric axis applied by the motor at the proximal end are transmitted from the proximal end to the distal end, thereby rotating the distal end about the central geometric axis,

[0178] wherein the hollow tube may be provided with a distally facing circular cutting edge defining a mouth of a distal end of the hollow tube,

[0179] wherein the hollow tube may have a hollow elongated tubular sample acquisition portion at a distal portion of the hollow tube, the hollow elongated tubular sample acquisition portion having a smooth inner surface,

[0180] Wherein preferably the smooth inner surface is smooth to such an extent that when a reference biopsy is to be obtained, the cutting edge and distal end of the hollow tube are configured to be advanced into the tissue along the central geometric axis while being rotated by the motor at its proximal end and thereby cut a core of tissue, the core of tissue entering the sample acquisition portion of the hollow tube relative to the hollow tube through the mouth due to the advancement of the hollow tube, wherein the circumferential outer surface of the core at least partially abuts the smooth inner surface of the sample acquisition portion, thereafter the hollow tube is retracted from the tissue while being rotated by the motor at its proximal end, whereby the core of tissue is disengaged from the tissue by a tensile force caused by the retraction of the hollow tube and by an adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, which adhesion force holds the core in the sample acquisition portion having the smooth inner surface. When the sample is pulled back, the adhesion force combined with the rotation causes the sample at the distal end to rotate, thereby actually releasing the sample from the tissue by a tapering and twisting spiral thread generated by the rotation of the biopsy.

[0181] The above-mentioned object is also achieved by a biopsy instrument, which includes a base member extending from a proximal end to a distal end along a central geometric axis, wherein at least the distal portion of the base member is formed as an elongated hollow tube, the distal end is intended to be rotated and at least partially inserted into a tissue from which a biopsy is to be obtained, wherein the hollow tube is provided with a distally facing circular cutting edge, the distally facing circular cutting edge defines a mouth of the distal end of the hollow tube, wherein the hollow tube has a hollow elongated tubular sample acquisition portion at the distal portion of the hollow tube, and the hollow elongated tubular sample acquisition portion has a smooth inner surface.

[0182] It is noted that it is also contemplated that for some user scenarios, the inner elongate hollow tubular member (rigid or flexible) may be manually rotated at the proximal end, thereby causing the distally facing circular cutting edge to rotate. BRIEF DESCRIPTION OF THE DRAWINGS

[0183] The invention will now be described in more detail, by way of example, with reference to the accompanying schematic drawings, which show currently preferred embodiments of the invention.

[0184] Figure 1a A physician is schematically disclosed obtaining a tissue sample from a patient using a biopsy instrument and an endoscope according to an embodiment.

[0185] Figure 1b A physician is schematically disclosed obtaining a tissue sample from a patient using a biopsy instrument and an endoscope according to another embodiment.

[0186] Figure 2a More details disclosed Figure 1a The proximal end of the endoscope and the proximal end of the biopsy instrument.

[0187] Figure 2b More details disclosed Figure 1b The proximal end of the endoscope and the proximal end of the biopsy instrument.

[0188] Figure 3a A distal end of the endoscope and a distal end of a base member are disclosed, the distal end of the base member being pushed out of the outer elongated hollow member and into tissue from which a sample is to be obtained.

[0189] Figure 3b A distal end of an endoscope and a distal end of a base member are disclosed, the distal end of the base member being advanced into tissue from which a sample is to be obtained.

[0190] Figure 4 Public Figure 3b The endoscopes and instruments shown, several samples of which have been obtained.

[0191] Figure 5 The tissue is shown after several samples have been obtained.

[0192] Figure 6 Harvesting a sample from a biopsy device is disclosed.

[0193] Figure 7 The use of overpressure provided by a syringe for harvesting is disclosed.

[0194] Figure 8 An interior of a manipulation member configured to be attached to a proximal end of a biopsy instrument is disclosed.

[0195] Fig. 9 Public Figure 8The exterior of the manipulation component and the manipulation buttons.

[0196] Fig.10 A manipulation member attached to a proximal end of a biopsy instrument is disclosed.

[0197] Fig.11 A flexible biopsy instrument is disclosed.

[0198] Fig.12 The inner elongate flexible hollow member is disclosed in greater detail in cross-section and exploded views.

[0199] Figure 13a to Figure 13b A first position and a second position of a distal end of a biopsy instrument when obtaining a tissue sample along a surface of tissue are disclosed.

[0200] Fig.13c It is disclosed how the telescopic function can be manipulated to obtain tissue samples along the surface of the tissue.

[0201] Fig.14a Publicly disclosed as Figure 13a to Figure 13b The distal end of a biopsy instrument is seen in cross-section as it is taken along the surface of tissue.

[0202] Fig.14b Disclosed is a tissue having a recess in the surface, the recess being Figure 13a to Figure 13b and Fig.14a Shown is formed by a biopsy instrument.

[0203] Fig.14c yes Fig.14b A top plan view of the organization and recess.

[0204] Fig.15 is a cross-sectional view of a biopsy instrument according to a second embodiment.

[0205] Fig.16 yes Fig.15 Another cross-sectional view of the biopsy instrument.

[0206] Fig.17 The invention discloses a method for use in endoscopes. Fig.15 and Fig.16 Schematic diagram of the biopsy instrument.

[0207] Fig.18 It is publicly available Figures 15 to 17 Schematic diagram of the same type of biopsy instrument in FIG. 1 connected to a variation of a telescope mechanism between the motor and the biopsy instrument.

[0208] Fig.19 More details disclosed Fig.18 The telescopic mechanism shown.

[0209] Fig. 20 yes Fig.18 and Fig.19 Cross-sectional view of the telescopic mechanism.

[0210] Fig.21 yes Figures 18 to 20 Exploded view of the telescopic mechanism.

[0211] Fig. 22 A motor, a telescoping mechanism, and a biopsy instrument are disclosed, and an example of a biopsy instrument interface is schematically disclosed, the interface being configured to be connected to the telescoping mechanism.

[0212] Fig.23 A rigid outer hollow needle and a rigid inner hollow needle configured to be positioned within the rigid outer hollow needle are disclosed.

[0213] Fig.24 A rigid inner hollow needle inserted into a rigid outer hollow needle is disclosed.

[0214] Fig.25 A rigid inner hollow needle and a rigid outer hollow needle are disclosed with the rigid inner hollow needle in a retracted position in which the needles are configured to be manipulated and inserted into a handle for manipulation in a sample acquisition method.

[0215] Fig.26a A needle is disclosed positioned in a handle and in a state ready to obtain a biopsy sample.

[0216] Figure 26b Operation of the handle to obtain a biopsy sample is schematically disclosed.

[0217] Fig. 27 is an overview of the system including the motor, telescopic mechanism, and biopsy instrument.

[0218] Fig.28 shows the connection to the endoscope Fig. 27 The telescopic mechanism.

[0219] Figure 29 to Figure 30 More details disclosed Figure 27 to Figure 28 The telescopic mechanism shown.

[0220] Figure 31 to Figure 32 Public Figures 27 to 30 A variation of the telescopic mechanism shown.

[0221] Detailed Description of the Preferred Embodiments

[0222] exist Figure 1a to Figure 1bIn the invention, it is generally disclosed how a user U (such as a physician) uses an endoscope 40 to guide a biopsy instrument 1 through a body cavity of a patient P to a sample site 50. The biopsy instrument 1 is inserted into the patient's body to the intended sample site 50 by inserting the endoscope 40 through the patient's body cavity and as the biopsy instrument 1 is inserted into the working channel 41 of the endoscope 40. Figure 1a to Figure 1b shown and in Figure 2a to Figure 2b As shown in more detail in FIG, the endoscope is provided with an access opening 41a at the proximal end of the remaining part outside the patient's body, wherein the biopsy instrument 1 is intended to be inserted into the endoscope via the access opening 41a. The endoscope 40 is typically provided with a camera and / or an ultrasound probe, and the endoscope 40 is typically connected to a screen 44 via a processing unit 45, which is capable of converting data from the camera or ultrasound probe into an image on the screen 44.

[0223] The biopsy instrument 1 comprises a base member 10 extending along a central geometric axis A from a proximal end 10a to a distal end 10b.

[0224] Fig.11 An embodiment of a complete biopsy instrument 1 is shown in FIG. Fig.11 In the illustrated embodiment, the base member 10 is flexible from a curved perspective. Thus, the base member can extend along the central geometric axis A and thus have a variety of shapes, which are typically required for a biopsy instrument 1 used in an endoscope 40. Such a flexible biopsy instrument 1 used in an endoscope 40 is sometimes referred to as an endoscopic biopsy instrument 1. However, it can be noted that the biopsy instrument 1 is also useful for applications not used in an endoscope. In this case, the biopsy instrument can be rigid from a curved perspective and extend with the central geometric axis A extending in a straight line. Such a rigid biopsy instrument is typically used as a stand-alone biopsy instrument 1.

[0225] The proximal end 10a is used in the environment Figure 1a to Figure 1b and Figure 2a to Figure 2b As shown in FIG. 1 , the distal end 10 b is used in its application environment, for example, in Figure 3a to Figure 3b and Figure 4 Shown in.

[0226] It can be noted that in Figure 1a In the embodiment, the manipulation unit 30 with the motor 31 is a separate box configured to be positioned on a stand or the like. The biopsy instrument includes a telescopic mechanism 101 and is connected to the motor 31 via a drive line 39. For more details, refer to e.g. Figures 27 to 32 To provide.

[0227] It can be noted that in Figure 1b In the embodiment, the operating unit 30 with the motor 31 is designed as a handheld component.

[0228] It may be noted that in the descriptions relating to the manipulation of the distal end of the biopsy instrument, in most cases it is contemplated that the biopsy instrument may be used. Figure 1a or Figure 1b Any one of the operating units 30.

[0229] For example Figure 3a to Figure 3b and Figure 4 As shown, at least the distal end portion 10b' of the base member 10 is formed as an elongated hollow tube 10'. Fig.12 and Figure 15 to Figure 16 In the preferred embodiment shown in detail in FIG. 1 , the base member 10 is formed as a hollow tube 10 ′ extending from a proximal end 10 a to a distal end 10 b of the base member 10 .

[0230] like Figure 3a to Figure 3b and Figure 4 As shown, the distal end 10b of the elongated hollow tube 10' is intended to be at least partially inserted into a tissue 50 from which a biopsy is to be obtained. Figure 3a to Figure 3b and Figure 4 In the user case shown, the distal end 10b is completely inserted into the tissue, that is, the distal end 10b is inserted in such a way that the entire circumferential portion C is inserted into the tissue 50. Figure 13a to Figure 13b and Figures 14a to 14c In the user situation shown, the distal end 10 b is only partially inserted into the tissue, that is, the distal end 10 b is inserted in such a way that only a portion of the entire circumferential portion C is inserted into the tissue 50 .

[0231] The base member 10 is capable of transmitting force along the central geometric axis A, thereby transmitting the movement LF, LB of the proximal end 10a along the central geometric axis A to the movement LF, LB of the distal end 10b along the central geometric axis A. The base member 10 is also capable of transmitting torque about the central geometric axis A, thereby transmitting the rotation ω and torque T applied by the motor 31 about the central geometric axis A at the proximal end 10a from the proximal end 10a to the distal end 10b, thereby rotating the distal end 10b about the central geometric axis A. Therefore, the distal end 10b of the base member 10 is manipulable by advancing and retracting the proximal end 10a and by applying the rotation ω and torque T at the proximal end 10a.

[0232] Biopsy instrument 1 is intended to be used according to the above reference Figure 1a to Figure 1b The brief disclosure presented is used. Figure 1a to Figure 1b and Figure 2a to Figure 2bThe intended method of use is disclosed in more detail. The user U connects the proximal end 10a of the biopsy instrument 1 to the steering unit 30 having the motor 31. The distal end 10b of the biopsy instrument 1 is moved to the position where a tissue sample is to be obtained by moving the endoscope 40 and then by moving the distal end 10b of the biopsy instrument 1 relative to the endoscope 40. In this movement, the user U is guided by the image on the screen 44. Thereafter, the user U activates the motor 31 so that the rotation is transmitted to the distal end 10b of the biopsy instrument 1. Thereafter, the user U pushes the distal end 10b, which is formed as an elongated hollow tube 10' at at least the distal end portion 10b' of the base member 10, into the tissue 50 from which the tissue sample is to be obtained, while the distal end 10b is rotated by the motor 31. The distal end 10b is formed as an elongated hollow tube 10' at at least the distal end portion 10b' of the base member 10, and the hollow tube 10' has a circular cutting edge 11 facing the distal side, and the circular cutting edge 11 facing the distal side defines the mouth 10c of the distal end 10b of the hollow tube 10', thereby cutting the core 51 of the tissue 50, which core 51 passes through the mouth 10c relative to the hollow tube 10' into the sample acquisition portion 10b' of the hollow tube 10' due to the advancement LF of the hollow tube 10'. This advancement can be said to be the movement of the biopsy instrument 1 relative to the endoscope 40 in the direction extending from the proximal end 10a to the distal end 10b.

[0233] exist Figure 2a In the embodiment of the present invention, the propulsion is performed by operating the telescopic mechanism 101. Figure 2a As shown in the four small figures in the figure, the telescopic mechanism 101 is manipulated so that the outer elongated hollow tubular member 14, which is initially preferably located in the working channel 41 of the endoscope 40, is moved to a desired position relative to the tissue. Thereafter, the motor 31 is started so that the inner elongated hollow tube 10' begins to rotate. Thereafter, the telescopic mechanism 101 is manipulated so that the base member with the inner elongated hollow tube 10' is pushed out of the outer elongated hollow tubular member 14 and into the tissue. Thereafter, the telescopic mechanism 101 is manipulated so that the base member with the inner elongated hollow tube 10' is partially or completely retracted into the outer elongated hollow tubular member 14. The advancement and retraction of the inner elongated hollow tube 10' can be repeated until the desired number of samples are retrieved.

[0234] exist Figure 2b In the embodiment of the present invention, this advancement is performed by moving the steering unit 30 forward along the arrow LF relative to the endoscope 40 and the access opening 41a, so that the free distance I of the biopsy instrument 1 is reduced. Once the distal end 10b has been inserted to the desired depth d in the tissue 50, the user U then retracts the distal end 10b out of the tissue 50 while the distal end 10b is rotated by the motor 31, and the circumferential outer surface of the core 51 at least partially abuts against the smooth inner surface 12 of the hollow elongated tubular sample acquisition portion 10b', which is arranged at the distal portion 10b' of the hollow tube 10'.

[0235] The core 51 of the tissue 50 is detached from the tissue 50 by a pulling force caused by the retraction LB of the hollow tube 10' and by the adhesion force formed at the interface between the smooth inner surface 12 and the circumferential outer surface of the core 51, which holds the core 51 in the sample acquisition portion 10b' having the smooth inner surface 12.

[0236] In addition, the core 51 can be separated from the tissue 50 by shear force and / or tensile force. Without being limited by the following description, it can be considered that the sample acquisition part rotates at a high rotation speed relative to the tissue, thereby forming a liquid film between the inner surface of the sample acquisition part and the tissue core, which reduces the friction between the tissue core and the sample acquisition part. The formation of this film is enhanced by the high rotation speed.

[0237] Similarly, a liquid film can be formed on the outer surface of the sample acquisition part. If the inner surface is smooth, for example, with a surface roughness lower than 0.5 microns, the formation of the liquid film is strengthened. As long as the sample acquisition part is pushed further into the interior of the tissue, the tissue core does not rotate. When the sample acquisition part is no longer pushed into the tissue but is retracted, the tissue core in the sample acquisition part will adhere to the inner surface of the sample acquisition part and begin to rotate, thereby separating the sample core from the surrounding tissue by shear force and tearing or pulling force. The sample core will now rotate with the sample acquisition part. When the next sample core is to be obtained, the previous sample core will be further pushed into the sample acquisition part against the friction applied by the inner surface. The friction coefficient should be as small as possible, such as less than 0.10 or less than 0.06.

[0238] When the smooth inner surface is formed from steel (such as medical grade stainless steel), the surface roughness of the smooth inner surface is preferably less than 1.5 µm, preferably less than 1 µm, and when formed from a polymer-based material, the surface roughness is preferably less than 6 µm, such as between 1 µm and 6 µm.

[0239] For example, Figure 3a to Figure 3b and Figure 4 As schematically shown in Fig.12 and Fig.16 As shown in more detail in FIG. 1 , the hollow tube 10' is provided with a distally facing circular cutting edge 11 which defines a mouth 10c of the distal end 10b of the hollow tube 10'. In all preferred embodiments, for both the flexible variant and the rigid variant, the distally facing circular cutting edge 11 has a straight configuration as seen along the circumferential direction C of the mouth 10c. It is also preferred that the mouth 10c defines a plane having a normal parallel to the extension of the central geometric axis A when the central geometric axis passes through said plane of the mouth 10c. That is, in an embodiment, the hollow tube 10' is cut at the mouth 10c by a plane orthogonal to the longitudinal extension of the hollow tube 10'.

[0240] The hollow tube 10' has a hollow elongated tubular sample acquisition portion 10b' at a distal portion 10b' of the hollow tube 10', and the hollow elongated tubular sample acquisition portion 10b' has a smooth inner surface 12. The tubular sample acquisition portion 10b' has a length along the central geometric axis A, which is preferably sufficient to allow a plurality of samples 51, 52, 53, 54, 55 to be collected and positioned in the tubular sample acquisition portion 10b' one after another along the central geometric axis A. The length is preferably at least 10 times the inner diameter of the hollow tube 10', and more preferably at least 20 times. However, as mentioned above, the base member 10 is preferably formed by an elongated hollow tube 10' extending from the proximal end 10a of the base member 10 to the distal end 10b. It can therefore be said that the hollow elongated tubular sample acquisition portion 10b' is formed substantially from the distal end 10b all the way to the proximal end 10a.

[0241] The elongated hollow tube 10' can be designed to have a uniform cross section extending from the proximal end 10a to the distal end 10b; in addition, the hollow tube is provided with local irregularities in the form of specific design features at the proximal end 10a itself and / or at the distal end 10b itself. These local irregularities can be, for example, that the hollow tube 10' is provided with a connector 15 at the proximal end 10a, and / or that the hollow tube 10' is specially designed at the distal end 10b to provide the cutting edge 11 or to receive a separate component that provides the cutting edge 11.

[0242] The smoothness of the smooth inner surface 12 is such that Figure 3a to Figure 3b and Figure 4When obtaining a reference biopsy by the method shown, the cutting edge 11 and the distal end 10b of the hollow tube 10' are configured to be driven by the motor at the proximal end 10a thereof to rotate ω, T while being advanced into the tissue 50 along the central geometric axis A, thereby cutting a core 51 of the tissue 50, and the core 51 of the tissue 50 passes through the mouth 10c relative to the hollow tube 10' into the sample acquisition portion 10b' of the hollow tube 10' due to the advancement LF of the hollow tube 10', wherein the circumferential outer surface of the core 51 at least partially abuts the sample acquisition portion 10b' of the hollow tube 10'. The smooth inner surface 12 of the sample acquisition portion 10b' is formed, and thereafter, the hollow tube 10' is retracted from the tissue 50 while being rotated ω, T by the motor at its proximal end 10a, whereby the core 51 of the tissue 50 is separated from the tissue 50 by a tensile force caused by the retraction LB of the hollow tube 10' and by an adhesive force formed at the interface between the smooth inner surface 12 and the circumferential outer surface of the core 51, which holds the core 51 in the sample acquisition portion 10b' having the smooth inner surface 12. Preferably, the smoothness of the surface 12 is such that when a reference sample is performed using a biopsy instrument 1 of the type described above, the core 51 is separated from the tissue 50 during the retraction of the hollow tube 10' when the distal end 10b has been inserted into the tissue 50 by a distance equal to or greater than the inner diameter D10ci of the mouth 10c. However, it is acceptable in many cases that the smoothness of the surface 12 is such that when a reference sample is performed using the above-described type of biopsy instrument 1, the core 51 is detached from the tissue 50 during the retraction of the hollow tube 10' when the distal end 10b has been inserted into the tissue 50 by a distance of 1.3 times or more of the inner diameter D10ci of the mouth 10c. In addition, it is acceptable in many cases that the smoothness of the surface 12 is such that when a reference sample is performed using the above-described type of biopsy instrument 1, the core 51 is detached from the tissue 50 during the retraction of the hollow tube 10' when the distal end 10b has been inserted into the tissue 50 by a distance of 1.7 times or more, or even 2 times or more of the inner diameter D10ci of the mouth 10c. The above is applicable at least to inner diameter D10ci between 1 mm and 5 mm.

[0243] It can be noted that the smallest or most superficial sample that can typically be obtained typically depends on the type of tissue and tumor being sampled. In general, more solid tissues and tumors are easier to sample, and typically biopsies as small as 1 mm can be performed. In mucosa, it also depends on which organ the biopsy is retrieved from, because the consistency is also different, such as the relatively soft gastrointestinal tract and the relatively solid respiratory tract. In most types of tissues and tumors, biopsies between 1 mm and 3 mm can typically be obtained with high reproducibility.

[0244] like Figure 4As shown, the biopsy instrument 1 is capable of retrieving multiple tissue samples directly one after another without the need to harvest a previous sample. As the distal end 10b is advanced into the tissue 50, the first sample 51 is further pushed into the hollow tube 10' toward the proximal end 10a by the core 52 of the second sample in a controlled manner. The hollow tube 10' is provided with a smooth inner surface 12, the smoothness of which allows the core 51 to adhere to the inner side of the hollow tube 10' with its own adhesiveness, a fact which allows the sample to be retrieved with minimal damage to the sample 51 and still allows the cutting edge 11 and the distal end 10b to drill into and out of the tissue 50, thereby reducing discomfort to the patient. Figure 4 In FIG. 1 , a variant without an outer elongated hollow tubular member is depicted. It can be noted that a biopsy instrument including an outer elongated hollow tubular member 14, such as, for example Figure 2a and Figure 3a The one disclosed in , may also be used to retrieve multiple samples by advancing and retracting the hollow tube 10 ′ relative to the outer elongated hollow tubular member 14, or alternatively by advancing and retracting the hollow tube 10 ′ and the outer elongated hollow tubular member 14 together relative to the endoscope 40 to retrieve multiple samples.

[0245] The hollow tube 10' is liquid-tight and air-tight or gas-tight. However, it should be noted that liquid-tight and air-tight or gas-tight is not intended to solve any long-term liquid-tight and air-tight or gas-tight problems, which are typically discussed when long-term storage of liquids or gases is involved. The hollow tube 10' should be liquid-tight and air-tight or gas-tight so that when the hollow tube 10' is retracted, suction is provided at the interface between the inner side wall of the hollow tube 10' and the core 51 of the tissue sample. The hollow tube 10' is liquid-tight and air-tight or gas-tight along at least the length of the tubular sample acquisition portion 10b' along the central geometric axis A. The tubular sample acquisition portion 10b' preferably has an extension and is provided with said smooth surface 12 along a length 10b' from the distal end 10b towards the proximal end 10a, the extension 10b' having a length at least allowing to acquire one after another at least two, preferably at least three reference samples of the above disclosed type, each having an insertion depth at least equal to the inner diameter D10ci, or at least 1.3 times, or at least 1.7 times, or even 2 times the inner diameter D10ci. In a preferred embodiment, the hollow tube 10' is airtight along the entire length from the proximal end 10a to the distal end 10b.

[0246] like Figure 6As shown, samples 51, 52, 53, 54, 55 can be harvested in a controlled manner so that each sample 51, 52, 53, 54, 55 remains uniquely identifiable and remains intact. This allows the physician to retain any information provided by the body layer and / or location of the corresponding sample 51, 52, 53, 54, 55, which in turn can be used to increase the amount of data provided by the biopsy, which in turn can improve the accuracy of the diagnosis ultimately provided.

[0247] Harvesting can be done, for example, by using Figure 6 The mechanical tool schematically indicated by the middle arrow 71 is inserted and extends from the proximal end 10a through the complete biopsy instrument to the distal end 10b, so that the samples 51, 52, 53, 54, 55 can be safely pushed out. Figure 7 As shown, the elongated hollow tube 10' also allows the use of an air jet at the proximal end 10a to push the sample 51, 52, 53, 54, 55 out at the distal end 10b for harvesting. The latter would require that the elongated tube 10' be sufficiently air-tight so that a sufficient amount of air or other type of gaseous or liquid fluid is ejected to actually push the sample 51, 52, 53, 54, 55 out. The air jet can be provided, for example, by a syringe 70 connected to the proximal end 10a of the hollow tube 10'.

[0248] Preferably, the smooth inner surface 12 is formed of a polymer-based material 12. The polymer-based material may be, for example, ethylene tetrafluoroethylene ETFE. It is also conceivable to use other plastic materials, such as other fluoropolymers, such as polytetrafluoroethylene PTFE, perfluoroalkoxy PFA, fluorinated ethylene propylene FEP. The inner surface may also be at least partially made of medical grade stainless steel, which is polished to the desired smoothness.

[0249] It can be noted that the polymer-based material 12 can be provided in a variety of different physical designs. The polymer-based material 12 can be provided in the form of an elongated tubular member. The polymer-based material 12 can be attached to the inside of the outer member. The polymer-based material 12 can be disposed within the outer member and can be moved and rotated relative to the outer member. The polymer-based material 12 can be provided as a coating within the outer member. The various physical designs will be discussed in more detail below.

[0250] It can be noted that in the above detailed description, the design of the hollow tube 10' and the movement of the hollow tube 10' relative to the tissue 50 have been discussed per se. The other parts of the biopsy instrument 1 can be designed in several different ways to achieve the expected movement of the hollow tube 10' in a suitable manner in different usage scenarios. Different embodiments indicating representative selections of some of these different ways will be disclosed in detail below.

[0251] exist Fig.11and Fig.12 In the embodiment shown in detail in FIG. 1 , the inner elongate hollow tubular member 13 includes a smooth inner surface 12 formed of a polymer-based material that is rotationally and translationally fixed relative to the inside of a support portion of the inner elongate hollow tubular member 13 .

[0252] like Fig.12 As shown, the supporting portion of the inner elongated hollow tubular member 13 includes a hollow metal wire 13', which is capable of transmitting force along the central geometric axis A, so that the movements LF, LB of the proximal end 10a along the central geometric axis A are transmitted to the movements LF, LB of the distal end 10b along the central geometric axis A, and the hollow metal wire 13' is capable of transmitting torque around the central geometric axis A, so that the rotation ω and torque T around the central geometric axis A applied by the motor 31 at the proximal end 10a are transmitted from the proximal end 10a to the distal end 10b, thereby causing the distal end 10b to rotate around the central geometric axis A.

[0253] For example, Fig.11 and Fig.12 As shown, the hollow tube 10 ′ has, at its proximal end 13 a , a connector 15 for connection to a motor 31 , the connector 15 being able to transmit said movements LF, LB along the central geometric axis A and being able to transmit said rotation ω and torque T.

[0254] The hollow tube 10' further comprises an outer layer 13" which is disposed outside the elongated hollow tubular member 13. The outer layer 13" may be, for example, a polymer-based shrink film.

[0255] like Fig.12 As shown, the hollow tube 10 ′ is designed according to the first embodiment, and optionally also manufactured according to the following.

[0256] An end tube 16 is mounted to the distal end 10b of the hollow metal wire rope 13'. The distal end 10b has been ground. The end tube 16 is provided with a cutting edge 11. The cutting edge 11 can be sharp. The end tube 16 also has an opening 16b used in the laser welding process, through which the end tube 16 is fastened to the outside of the hollow metal wire rope 13'. The distal end of the end tube can be laser welded to the surface of the hollow metal wire rope around the entire circumference of the rope. The base connector 17 is crimped or shrunk onto the proximal end 10a of the hollow metal wire rope 13'. The base connector 17 is in turn designed to be connected to the connector 15, wherein the connector 15 is designed to be connected to the manipulation unit 30. In a sense, it can be said that the base connector 17 forms a part of the connector 15. The connectors 15, 17 are manufactured as two main components 15, 17, because it is advantageous for the component 17 that is actually attached to the hollow metal wire rope 13' to have a small and straightforward design. The desired functionality regarding the user-friendly connection between the connector 15 and the steering unit 30 is then provided by the connector 15. The connection between the base connector 17 and the connector 15 is such that it is possible to transmit the force along the central geometric axis A and to transmit the torque around the central geometric axis A, so that the rotation ω and the torque T can be transmitted.

[0257] The smooth inner surface 12 is provided by an inner material located inside the hollow metal wire 13'. In the disclosed embodiment, the inner material is in the form of a polymer-based film, preferably a tubular polymer-based film. The inner material 13 is welded to the hollow metal wire 13'. When the inner material is positioned inside the hollow metal wire 13', the inner material preferably has an excess length compared to the length of the hollow metal wire 13' and is welded and fixed in its proper position before the inner material is cut flush. It can also be mentioned that, preferably, the cutting edge 11c is also flush with the distal end 10a of the hollow tube 10'. Thereby the smooth surface 12 will extend all the way to the distal end 10a.

[0258] The outer shrink tube shrinks to the outside of the hollow metal wire 13'.

[0259] It can be noticed that we can also think of Fig.12The inner material 13 is shown to be rotatably and translationally movable relative to the support portion 13'. The inner material 13 can be, for example, a hollow polymer-based elongated tube 13 that forms the base member 10 and has sufficient rigidity to be able to transmit forces along the central geometric axis A, thereby transmitting the movement LF, LB of the proximal end 10a along the central geometric axis A to the movement LF, LB of the distal end 10b along the central geometric axis A, and to be able to transmit torque around the central geometric axis A, thereby transmitting the rotation ω and torque T applied by the motor 31 at the proximal end 10a around the central geometric axis A from the proximal end 10a to the distal end 10b, thereby rotating the distal end 10b around the central geometric axis A. In this design, the hollow metal wire 13' will form a stationary outer elongated hollow tubular member 14. In this design, the distal end 10b of the inner material 13 can form the cutting edge 11.

[0260] exist Fig. 27 In, an embodiment is disclosed, wherein reference Fig.12 The disclosed elongated member 10 has an inner polymer-based tube 13 secured inside a hollow metal wire 13 ′, the elongated member 10 being disposed inside an outer elongated hollow tubular member 14 such that it is independently rotationally and translationally movable relative to the outer elongated hollow tubular member 14 .

[0261] Regardless of the specific design of the base member 10, the outer elongated hollow tubular member 14 may be a hollow metal wire. Preferably, the inner tubular member 13 is formed of a hollow metal wire and the outer elongated hollow tubular member 14 is formed of a hollow metal wire. Optionally, the outer elongated hollow tubular member 14 may be provided with an inner tube, such as a polymer-based tube.

[0262] Alternatively, refer to Fig.12 The disclosed base member 10, which has an inner polymer base tube 13 fixed inside a hollow metal wire 13', can be arranged in a working channel 41 of an endoscope 40 so that it can be independently moved rotationally and translationally relative to the working channel 41. In this design, the working channel 41 of the endoscope 40 can be said to be formed as an outer elongated hollow tubular member 14 in a sense.

[0263] However, it is preferred that the outer elongated hollow tubular member 14 forms part of the biopsy instrument 1. For use with an endoscope 40, preferably the biopsy instrument 1 is provided with the outer elongated hollow tubular member 14 and a base member 10, which is independently movable rotationally and translationally relative to the outer elongated hollow tubular member 14, and the biopsy instrument 1 is in turn inserted into the working channel 41 of the endoscope 40. With this design, the outer elongated hollow tubular member 14 is movable translationally and preferably also rotatable within the working channel 41. However, this movability and rotatability is intended for positioning the outer elongated hollow tubular member 14 relative to the endoscope 40 and relative to the tissue 50, while the rotation intended for the cutting edge 11 to cut the tissue 50 is provided by rotating the base member 10 relative to the outer elongated hollow tubular member 14.

[0264] refer to Fig.15 and Fig.16 , the following embodiments will be described in more detail below, in which the inner elongated hollow tubular member 13 is arranged inside the outer elongated hollow tubular member 14 and is rotatably and translationally movable relative to the outer elongated hollow tubular member 14. The inner elongated hollow tubular member 13 may be, for example, a reference Fig.12 The disclosed one, wherein the inner material is fixed to the hollow metal wire 13'. During the process of obtaining the sample, the outer elongated hollow tubular member 14 is intended to remain stationary relative to the endoscope. The inner elongated hollow tubular member 13 is intended to be rotated and advanced into the tissue 50, while the outer elongated hollow tubular member 14 remains outside the tissue 50. Fig.16As shown, the distal end 14b of the outer elongated hollow tubular member 14 is provided with a stopper 19. The stopper 19 prevents the distal end 14b from being accidentally advanced into the tissue 50. The stopper 19 is designed to increase the abutment surface between the distal end 14b of the outer elongated hollow tubular member 14 and the tissue 50. The stopper 19 provides this increased abutment surface by being positioned at the distal end 14b and being designed to provide one or more bodies that increase the circumferential portion of the distal end 14b. The stopper 19 can be an expandable ring 19 attached to the outer elongated hollow tubular member 14. The stopper 19 can be one or more arms 19' that are pivotally connected to the outer elongated hollow tubular member 14. When the inner elongated hollow tubular member 13 is retracted, the enlarged abutment surface provided by the stop 19 brings stability and works as a counterforce, thereby making it easier to remove the sample without causing too much tension on the tissue surrounding the sample site. In addition, by allowing the outer elongated hollow tubular member 14 to remain stationary relative to the endoscope during the sample acquisition process, combined with the inner elongated hollow tubular member 13 being rotatably and translationally movable relative to the outer elongated hollow tubular member 14, the outer elongated hollow tubular member 14 can be designed to fit relatively tightly with the working channel 41 of the endoscope. In addition, since relative movement is provided between the two components of the instrument (the two components are specifically designed and manufactured to interact with each other), a relatively tight fit can be provided between the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14, and still ensure that sufficient clearance is provided. Furthermore, since a tight fit can be used, the inner elongate hollow tubular member 13 and the outer elongate hollow tubular member 14 will in a sense support each other and prevent each other from collapsing, which in turn makes it possible to use relatively thin material thicknesses in both the outer elongate hollow tubular member 14 and the inner elongate hollow tubular member 13. For a given working channel 41 with a given inner diameter, this will in turn make it possible for the distal end 13b of the inner elongate hollow tubular member 13 to have a relatively large inner diameter D10ci.

[0265] The inner elongated hollow tubular member 13 is capable of transmitting force along the central geometric axis A, so that the movements LF and LB of the proximal end 10a along the central geometric axis A are transmitted as the movements LF and LB of the distal end 10b along the central geometric axis A, and the inner elongated hollow tubular member is capable of transmitting torque around the central geometric axis A, so that the rotation ω and torque T around the central geometric axis A applied by the motor 31 at the proximal end 10a are transmitted from the proximal end 10a to the distal end 10b, thereby causing the distal end 10b to rotate around the central geometric axis A.

[0266] The inner elongated hollow tubular member 13 has at its proximal end 13a a connector 15 for connection to the motor 31 , the connector 15 being able to transmit along the central geometric axis A said movements LF, LB and said rotations ω and torques T.

[0267] The outer elongated hollow tubular member 14 has a connector 18 at its proximal end 14a for connecting to the manipulation unit 30, so that the outer elongated hollow tubular member 14 can be moved to the desired sample site and remain stationary during sample acquisition, and the sample is acquired by advancing the inner elongated hollow tubular member 13 LF and retracting LB when the inner elongated hollow tubular member 13 is rotated by the motor 31.

[0268] The inner elongated hollow tubular member 13 is provided with the distally facing circular cutting edge 11 at its distal end. Fig.12 As discussed, the cutting blade 11 may be provided on a separate member such as the end tube 16. However, since the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14 support each other and can therefore be designed to have a thin material thickness, it is conceivable to use the cutting distal end of the inner elongated hollow tubular member 13, such as the cutting blade 11.

[0269] If the diameter of the mouth defined by the cutting blade is 1 mm and the rotation speed is 15000 rpm, the circumferential speed of the cutting blade will be 0.75 m / s. It is currently believed that the cutting blade will effectively cut off tissue if the circumferential speed exceeds about 0.40 m / s. Such a circumferential speed gives the cutting blade a cutting radius of about 0.02 mm, which corresponds to a relatively blunt cutting blade. The cutting radius can be smaller. A blunt cutting blade with a cutting radius of 0.01 mm to 0.02 mm is convenient from a handling perspective because the blunt cutting blade will not easily injure the user when the user accidentally hits the cutting blade during handling, and the blunt cutting blade is still effective for the biopsy procedure. In the biopsy procedure, a cutting blade with a cutting radius of 0.001 mm to 0.01 mm will be more effective when cutting tissue. A larger cutting blade diameter, such as 2 mm or optionally 4 mm will result in a higher circumferential speed of about 1.5 m / s, individually 3 m / s, which is still better from the perspective of an efficient biopsy procedure.

[0270] The manipulation unit 30 briefly includes a housing 32, an electric motor 31 in the housing 32, and a connector 33. The connector 33 is configured to be interconnected with the connector 15 and connected to the motor 31, so that the torque T and the rotation ω can be transmitted from the motor 31 to the connector 15. The manipulation unit 30 also includes one or more batteries 34a to 34b. The manipulation unit 30 may be provided with one or more buttons 35a to 35b. The buttons 35a to 35b may, for example, be used to start and stop the motor 31. As exemplarily shown by the connection 36, the manipulation unit 30 may be provided with one or more electrical connections. The connection 36 may, for example, be used to provide an interface to a pedal 37, which is shown in Figure 1, whereby the pedal 37 may be used to start and stop the motor 31. The user U may, for example, be given the option of changing the rotation speed by stepping on / relaxing the pedal 37. The connection 36 may also be used to charge the batteries 34a to 34b in the manipulation unit 30. The connection portion 36 and the housing 32 may be configured to receive a connector 80 extending from the connection portion 36, such as, for example Figure 8 As shown as a typical connector 80 located at one end of the wire 81. The connecting portion 36 and the housing 32 can be configured to receive a sub-housing 82 having the shape and size of the extension portion 32' forming the housing 32. The sub-housing can, for example, have the same circumferential shape and size, and as Fig. 9 and Fig.10 Attached to the end of the housing 32 as shown. The wire 81 can extend from this part 32' of the housing 32. This extension part 32' of the housing 32 can accommodate the batteries 34a to 34b. Therefore, the batteries 34a to 34b can be quickly replaced, these batteries can be charged separately from the housing part including the motor 31 and the connector 33, and a single steering unit 30 with a motor 31 and a connector 33 and more than one extension part 32' can be used, each extension part 32' being provided with its own set of one or more batteries 34a to 34b.

[0271] exist Fig.10 3 shows how the steering unit 30 is connected to the biopsy instrument 1 via the connector 15 , which is connected to the connector 33 .

[0272] exist Fig.17, a telescoping mechanism 90 is shown. The telescoping mechanism may also be referred to as a telescoping function. The telescoping mechanism 90 may include a cover 91 that at least partially, but preferably completely, covers the portion of the biopsy instrument 1 between the access opening 41a and the manipulation unit 30. The telescoping mechanism 90 may have an adjustable length along the axis A so that a biopsy instrument 1 having a certain length may be used in different kinds of endoscopes 40 having working channels 41 of slightly different lengths (as measured between the access opening 41a and the distal opening 41b). The telescoping mechanism 90 may also provide a limitation on the maximum extension of the distal end 10b of the elongated hollow tubular member 10 and / or a limitation on the maximum extension of the distal end 14b of the outer elongated hollow tubular member 14. The telescoping mechanism 90 may also be provided with a locking member 92 by which the outer elongated hollow tubular member 14 may be fixed relative to the endoscope 40 once the biopsy instrument 1 has been moved to the intended sample site. The telescoping mechanism 90 may also be provided with a locking member or abutment member 93, by which the maximum relative movement between the inner elongate hollow tubular member 13 and the outer elongate hollow tubular member 14 can be set, thereby providing a well-defined maximum sample depth. Fig.17 In the figure, for the sake of clarity, the endoscope 40 and the distal end of the biopsy instrument 1 are shown enlarged. However, in practice, the biopsy instrument 1 typically has the same diameter at the distal end portion 10b' as the diameter of the rest of the length of the biopsy instrument, such as Fig.19 shown.

[0273] Figures 18 to 22 The telescopic mechanism 100 shown is particularly configured for Figure 15 to Figure 16 , i.e., a biopsy instrument having a non-rotating outer elongated hollow tubular member 14 and an inner elongated hollow tubular member 13 rotatably arranged within the outer elongated hollow tubular member 14. The proximal end of the telescoping mechanism 100 is connected to the motor 30, while the distal end of the telescoping mechanism 100 is connected to the endoscope 40. Different parts of the telescoping mechanism 100 are connected to different parts of the biopsy instrument 1, which will be disclosed in more detail below.

[0274] The telescopic mechanism 100 includes a base sleeve 110. The base sleeve 110 is provided with a connector 111 at its distal end, and the base sleeve 110 is configured to be connected to the insertion opening 41a of the endoscope 40 through the connector 111. The motor 30 is configured to be connected to the proximal end of the base sleeve 110. The base sleeve 110 has a fixed length. It can be noted that the connector 111 of the disclosed different telescopic mechanisms 90, 100, 101 is preferably rotatable relative to the telescopic mechanism 90, 100, 10 about the central geometric axis A, whereby the telescopic mechanism 90, 100, 101 can be rotated relative to the insertion opening 41a of the endoscope about the central geometric axis A. It can be noted that such rotatability does not mean that the telescopic mechanism is intended to be rotated by any motor or any other type of continuous rotation. The rotation is intended to allow the physician to orient the telescopic mechanism relative to the endoscope, thereby achieving easy access to the various manipulation components of the telescopic mechanism.

[0275] The telescoping mechanism 100 further comprises an inner sleeve 120 slidably arranged within the base sleeve 110. The inner sleeve 120 is connected to the outer elongated hollow tubular member 14 such that sliding movement of the inner sleeve 120 relative to the base sleeve 110 in the distal direction causes the outer elongated hollow tubular member 14 to move in the distal direction relative to the endoscope. The telescoping mechanism 100 further comprises a first annular member 115 movably arranged around the base sleeve 110. The first annular member 115 can slide back and forth along the base sleeve 110. It can be said that the length of the outer elongated hollow tubular member 14 at the distal end of the endoscope 40 is controlled. The first annular member 115 is provided with a connector 116, which in the disclosed embodiment is a screw and a wedge, by which the first annular member 115 can be connected to the inner sleeve 120. In the disclosed embodiment, a screw is positioned in a threaded hole of the first annular member 115, and when the screw is screwed into the threaded hole of the first annular member 115, the screw pushes the wedge into contact with the inner sleeve 120, which can be said to adjust the length of the outer elongated hollow tubular member 14 distally out of the endoscope. The connector 116 extends through the through slot 112 formed in the wall of the base sleeve 110. By moving the first annular member 115 to a desired position relative to the inner sleeve 120, and connecting the first annular member 115 to the inner sleeve 120 by activating the connector 116 at the desired position, combined with the fact that the connector 116 extends through the slot 112, this can define the extent to which the outer elongated hollow tubular member 14 can be moved out of the distal opening 41a of the endoscope 40. When the connector 116 connected to the inner sleeve 120 and extending through the slot 112 reaches the distal end of the slot 112 , the connector 116 , and thus also the first annular member 115 and the inner sleeve 120 , are prevented from any further movement in the distal direction relative to the base sleeve 110 .

[0276] The telescoping mechanism 100 also includes a center sleeve 130 slidably disposed within the inner sleeve 120. The center sleeve 130 is connected to the inner elongated hollow tubular member 13 such that sliding movement of the center sleeve 130 relative to the inner sleeve 120 in a distal direction causes the inner elongated hollow tubular member 13 to move in a distal direction relative to the outer elongated hollow tubular member 14. The inner elongated hollow tubular member 13 is rotatable within the center sleeve 130. In a preferred embodiment, the inner elongated hollow tubular member 13 extends through the center sleeve 130 in a bore 131 having a diameter such that there is a gap between the inside of the bore 131 and the inner elongated hollow tubular member 13.

[0277] The telescoping mechanism 100 further comprises a second annular member 125 which is movably arranged around the base sleeve 110. The second annular member 125 can slide back and forth along the base sleeve 110. The second annular member 125 is provided with a connector 126, which in the disclosed embodiment is a screw and a wedge, by which the second annular member 125 can be connected to the central sleeve 130. In the disclosed embodiment, the screw is positioned in a threaded hole of the second annular member 125, and when the screw is screwed into the threaded hole of the second annular member 125, the screw pushes the wedge into contact with the central sleeve 130. The connector 126 extends through a through slot 113 formed in the wall of the base sleeve 110, and through a through slot 121 in the inner sleeve 120. By moving the second annular member 125 to a desired position relative to the central sleeve 130 and connecting the second annular member 125 to the central sleeve 130 at the desired position by activating the connector 126, combined with the fact that the connector 126 extends through the slot 121 in the inner sleeve 120, this can define the extent to which the inner elongated hollow tubular member 13 can be moved outside the outer elongated hollow tubular member 14. When the connector 126 connected to the central sleeve 130 and extending through the slot 121 reaches the distal end of the slot 121, the connector 126 and therefore also the second annular member 125 and the central sleeve 130 are blocked from any further movement in the distal direction relative to the inner sleeve 120.

[0278] The telescoping mechanism 100 also includes a connector 135 configured to interconnect the center sleeve 130 and the inner sleeve 120 in a desired relative position, as seen along the direction in which the center sleeve 130 is slidable relative to the inner sleeve 120. In the disclosed embodiment, the connector 135 is connected to the center sleeve 130 at a fixed position along the sliding direction. The connector 135 extends through a through slot 122 formed in the wall of the inner sleeve 120 so that the connector 135 is accessible to a user and so that the center sleeve 130 can slide relative to the inner sleeve 120 without the connector 135 preventing such sliding movement. The connector 136 is configured to be activated and interconnect the inner sleeve 120 with the center sleeve 130. In the disclosed embodiment, the connector 136 is further screwed into a threaded hole in the center sleeve 130 so that the head of the screw interacts with the wall of the inner sleeve 120 on the side of the slot 122.

[0279] It is noted that it is contemplated that the telescopic mechanism 100 may include the above disclosed and, for example, Figures 18 to 21 However, it is also conceivable that for certain applications it is desirable to present only one or two of the above functions.

[0280] For example, it is contemplated that for some applications it may be preferable to adjust the maximum length of the outer elongated hollow tubular member 14 extending beyond the distal opening 41 b of the endoscope 40 in conjunction with the adjustable maximum length that the inner elongated hollow tubular member 13 can move beyond the outer elongated hollow tubular member 14. Figure 3a to Figure 3b and Figure 4 As shown, this arrangement would typically be useful when a biopsy needs to be performed.

[0281] In an alternative embodiment, only one arrangement is available, namely the possibility of interconnecting the inner sleeve 120 and the central sleeve 130. Figure 13a to Figure 13b This arrangement is usually useful when performing a biopsy as shown. The user will set a fixed distance, which is the distance that the inner elongated hollow tubular member 13 extends beyond the outer elongated hollow tubular member 14, after which the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14 will move together relative to the distal opening 41b of the endoscope 40 to obtain a superficial sample from the surface of the organ wall, such as Figure 13a to Figure 13b and Figures 14a to 14c shown.

[0282] In this context, it can also be noted that the telescopic mechanism 90, 100 can be a separate component, i.e., independent of and connectable to the endoscope 40, the biopsy instrument 1 and the motor 31. Alternatively, the telescopic mechanism can, for example, form part of the biopsy instrument 1 and thus have an interface for connection to the motor 31 and optionally also an interface for connection to the endoscope 40. Fig.18 , schematically discloses how the manipulation unit 30 including the motor 31 is connected to the telescopic mechanism. Optionally, the telescopic mechanism 90, 110 can be connected to the telescopic mechanism 90, 110 by means of Fig. 27 The disclosed drive line 39 is connected to a steering unit 30 comprising a motor 31 .

[0283] exist Fig. 22 , schematically shows a design in which the telescopic mechanism 100 is independent of the biopsy instrument 1. The telescopic mechanism 100 can be an integral component of the manipulation unit 30, but alternatively can also be a separate component that can be connected to the manipulation unit 30. The biopsy instrument 1 includes an interface for connecting to the telescopic mechanism. The interface includes a first connecting member 13e, which is connected to the inner elongated hollow tubular member 13 and is configured to be connected to the central sleeve 130 of the telescopic mechanism 100. The interface includes a second connecting member 14e, which is connected to the outer elongated hollow tubular member 14 and is configured to be connected to the inner sleeve 120.

[0284] In actual biopsy sampling, the biopsy instrument 1 can be used according to a variety of different methods. The biopsy instrument can be used, for example, according to a method in which the biopsy instrument is shown in Figures 3 to Figure 5 1 is used as shown, i.e. the distal end 10b is advanced a distance into the tissue 50 and then retracted. However, according to another method, the biopsy instrument 1 can be used to move along the surface of the tissue 50 from which a biopsy is obtained, such as for example Figures 13a to 13c and Figures 14a to 14c As shown. Figures 3a to 3b and Figure 4 In the user method shown, the distal end 10b is fully inserted into the tissue 50, that is, when the distal end 10b is inserted, the entire circumferential portion C is inserted into the tissue 50, thereby forming an adhesion force that is greater than the breaking force required to separate the core from the tissue. Figures 13a to 13c and Figures 14a to 14c In the method shown, the distal end 10b is only partially inserted into the tissue 50, that is, the distal end 10b is inserted in a manner that only a portion of the entire circumferential portion C is inserted into the tissue 50, such as Fig.14a As shown. Fig.14a In the circumferential portion C, about half (in Fig.14a The lower half is inserted into the tissue 50. Figure 13a to Figure 13bAs shown, in this method, the biopsy instrument 1 is moved along the surface of the tissue 50 and cuts a substantially continuous or at least semi-continuous recess 57 in the surface of the tissue 50 .

[0285] The distal end of the base member rotates at a high speed, such as 13,000 rpm or more. This means that the distal end of the base member extending beyond the elongated tubular member will be stabilized, thereby counteracting deviations from a straight path. This is an advantage if the tissue is softer / harder at different locations, as is often the case with cancerous tumors. The sample will be removed according to a substantially straight path, without any deviation in the softness / hardness of the tissue. This particularly relates to the method according to Figures 3 to 4. Figure 5 Embodiments and basis Figures 13a to 14c Embodiment of the invention.

[0286] exist Figures 3a to 3b and Figure 4 In the illustrated user method, a telescoping mechanism, such as telescoping mechanism 100, can be configured such that the inner elongate hollow tubular member 13 is rotatable relative to the outer elongate hollow tubular member 14 and such that the inner elongate hollow tubular member 13 is translationally movable relative to the outer elongate hollow tubular member 14 between a proximal-most position in which the inner elongate hollow tubular member 13 is completely concealed within the outer elongate hollow tubular member 14 and a distal-most position in which the inner elongate hollow tubular member 13 extends a predetermined maximum distance outside of the outer elongate hollow tubular member 14. A telescoping mechanism, such as telescoping mechanism 100, can be configured such that the outer elongate hollow tubular member 14 is initially movable relative to the working channel 41 of the endoscope 40 and once the desired position of the distal end 14b of the outer elongate hollow tubular member 14 has been reached, the position of the outer elongate hollow tubular member 14 can be fixed relative to the endoscope 40.

[0287] exist Figures 13a to 13c and Figures 14a to 14cIn the user method shown, the telescoping mechanism, such as the telescoping mechanism 100, can be configured to allow the inner elongated hollow tubular member 13 to rotate relative to the outer elongated hollow tubular member 14, and to allow the inner elongated hollow tubular member 13 to initially translate relative to the outer elongated hollow tubular member 14 between a proximal-most position in which the inner elongated hollow tubular member 13 is completely concealed within the outer elongated hollow tubular member 14 and a distal-most position in which the inner elongated hollow tubular member 13 extends a predetermined maximum distance outside the outer elongated hollow tubular member 14, thereby When the biopsy instrument is inserted into the working channel 41 and positioned relative to the tissue 50, the inner elongated hollow tubular member 13 is hidden in the outer elongated hollow tubular member 14, and thereafter, the inner elongated hollow tubular member 13 is moved to the most distal position and fixed at the most distal position, so that the outer elongated hollow tubular member 14 can move along the tissue 50, wherein the distal end 13b of the inner elongated hollow tubular member 13 extends a predetermined distance outside the outer elongated hollow tubular member 14 (preferably fixed at the predetermined distance), and the inner elongated hollow tubular member 13 rotates relative to the outer elongated hollow tubular member 14. Fig.13c , it is shown how a user can move the telescoping mechanism 101 relative to the endoscope 40 so that the inner elongate hollow tubular member 13 and the outer elongate hollow tubular member 14 move together along the surface of the tissue.

[0288] In these cases, the base member 10 is flexible, and the elongated hollow tubular member 14 is also flexible, and the base member 10 is preferably rotated at a rotation speed of at least 13000 rpm. Preferably, the rotation speed is between 13000 rpm and 25000 rpm, and more preferably between 13000 rpm and 20000 rpm.

[0289] exist Fig.23 and Fig.24 In the embodiment of the present invention, a variant of the biopsy instrument 1 is disclosed, wherein the outer elongated hollow tubular member 14 is a rigid hollow needle 214. The inner elongated hollow tubular member 13 is also a rigid hollow needle 213. Fig.23 As shown, the rigid inner hollow needle 213 is configured to be positioned within the rigid outer hollow needle 214. Fig.24 As shown, the rigid inner hollow needle 213 has a length sufficient to extend beyond the distal opening of the rigid outer hollow needle 214. When the rigid inner hollow needle 213 and the rigid outer hollow needle 214 are operated, as shown in FIG. Fig.25 As shown, the rigid inner hollow needle 213 is preferably retracted so that it does not extend beyond the distal opening of the rigid outer hollow needle 214. Fig.25In the embodiment, the rigid inner hollow needle 213 and the rigid outer hollow needle 214 are to be positioned in the manipulation unit 200, which is used to manipulate the rigid inner hollow needle 213 and the rigid outer hollow needle 214 to obtain a biopsy. The rigid outer hollow needle 214 may have an inclined end, thereby facilitating the insertion of the rigid outer hollow needle 214 into the tissue to be sampled.

[0290] Furthermore, it is also conceivable to arrange an internal probe inside the rigid inner hollow needle 213. The internal probe may, for example, be provided with an inclined solid tip corresponding to the tip of the rigid outer hollow needle 214. When the biopsy instrument 1 is inserted into the tissue to be sampled, the internal probe may be used to cover the mouth of the rigid inner hollow needle 213, and the internal probe may be partially or completely removed before the rigid inner hollow needle 213 is rotated and / or inserted into the tissue.

[0291] This design with an internal probe can be used according to the following: the biopsy instrument 1 is moved to reach the sample site, for example, the biopsy instrument 1 is inserted into the tissue through the skin or via a body cavity, wherein the internal probe is positioned so that it closes the mouth of the rigid inner hollow needle during the movement of the biopsy instrument 1. Thereafter, the internal probe moves in the proximal direction so that the mouth of the rigid inner hollow needle 213 is opened. The internal probe moves at least a distance in the proximal direction, which is sufficient to open the distal portion of the rigid inner hollow needle 213, wherein the distal portion has a sufficient length to allow a sufficient amount of tissue to be retrieved into the rigid inner hollow needle 213. Thereafter, the rigid inner hollow needle 213 is advanced in the distal direction relative to the rigid outer hollow needle 214 (and simultaneously rotated) and the sample is obtained. The rigid inner hollow needle 213 is preferably rotated at a rotation speed of at least 3000 rpm. Thereafter, the rigid inner hollow needle member 213 is retracted into the rigid outer hollow needle member 214 and the biopsy instrument 1 is retracted from the sample site, preferably while still rotating. It may be noted that it is preferred to move the inner probe in the proximal direction before the rigid inner hollow needle member 213 is advanced, but it is sufficient to move the inner probe in the proximal direction at the latest while the rigid inner hollow needle member 213 is retracted into the rigid outer hollow needle member 214, so that the inner probe does not push the sample in the rigid inner hollow needle member 213 out of the rigid inner hollow needle member 213. After the biopsy instrument 1 has been removed from the sample site, the inner probe can be used to harvest a sample from the rigid inner hollow needle member 213 by moving the inner probe in the distal direction so that the inner probe pushes the sample out of the rigid inner hollow needle member 213. The inner probe may be rigid. The inner probe may be flexible and guided by the rigid inner hollow needle member. As Figures 4 to 6As shown, this embodiment can also be used to collect several consecutive samples, whereby the probe is completely removed or at least retracted so that the sample has room to accumulate within the rigid hollow needle 213.

[0292] It may be noted that the use of an inner probe may also be applicable to a flexible biopsy instrument 1 configured for use with an endoscope 40. In this case, the inner probe is also flexible and is guided by the inner elongate hollow tubular member 13.

[0293] like Fig.23 As shown, the rigid inner hollow needle 213 includes an interface section 213e, and the rigid outer hollow needle 214 also includes an interface section 214e.

[0294] exist Figure 26a to Figure 26b An example of a manipulation unit 200 is schematically shown in FIG. Fig.23 and Fig.24 A biopsy instrument 1 of the basic type disclosed in .

[0295] Fig.26a The needle is disclosed positioned in the manipulation unit 200 and is in a state ready to obtain a biopsy sample.

[0296] Figure 26b Operation of the handle 210 of the manipulation unit 200 to obtain a biopsy sample is schematically disclosed.

[0297] In more detail, the manipulation unit 200 comprises a base member 201 supporting the different components of the manipulation unit 200. The manipulation unit 200 comprises a support 202 configured to interact with an interface section 214e of a rigid outer hollow needle 214 and to hold the rigid outer hollow needle 214 in place. Preferably, the rigid outer hollow needle 214 remains fixed relative to the manipulation unit 200, i.e., the rigid outer hollow needle 214 is not movable in the longitudinal direction and is not rotatable relative to the manipulation unit 200.

[0298] The manipulation unit 200 also includes a sliding member or sled 203 configured to interact with the interface section 213e of the rigid inner hollow needle 213. The sled 203 also includes a motor 30, which is configured to rotate the rigid inner hollow needle 213 relative to the manipulation unit 200 and also rotate the rigid inner hollow needle 213 relative to the rigid outer hollow needle 214. The sled 203 is configured to move back and forth relative to the support 201 so that the distal end of the rigid inner hollow needle 213 can extend beyond the distal end of the rigid outer hollow needle 214, similar to Fig.24As shown, and the rigid inner hollow needle member can be retracted again, so that the distal end of the rigid inner hollow needle member 213 retreats into the rigid outer hollow needle member 214, so that the distal end of the rigid inner hollow needle member 213 no longer extends beyond the distal end of the rigid outer hollow needle member 214. These insertion and / or retraction operations can be manual, or these insertion and / or retraction operations can be automatic and can be electrically controlled by one or more buttons on the manipulation unit 200.

[0299] The sled 203 can be manipulated in a back-and-forth manner, for example, by means of a connecting rod 204 connected to a handle 205. By manipulating the handle 205 relative to the support 201, the sled 203 will be affected via the connecting rod 204. In a preferred embodiment, the manipulation unit 200 may include a second handle that is fixed relative to the support 201 and Figure 26a to Figure 26b The handle 205 shown in the figure can be moved towards such a fixed handle. For the sake of clarity, such a fixed handle is omitted.

[0300] Figure 23 to Figure 24 The biopsy instrument 1 is designed to be positioned in the manipulation unit 200 so that the interface 214e of the rigid outer hollow needle 214 interacts with the support 202 and the interface 213e of the rigid inner needle 213 interacts with the sled 203 and the motor 30 on the sled 203. The manipulation unit 200 is configured to be closed thereafter by closing or placing a cover 206 over the interface sections 213e and 214e of the rigid inner hollow needle 213 and the rigid outer hollow needle 214 and the associated components 202, 203 of the manipulation unit 200. The cover 206 may be hinged relative to the base member 201. The cover may be connected to the base member 201 in other suitable ways, such as slidably connected to the base member 201, a fully removable connection using a snap connection or the like, and the like.

[0301] The manipulation unit 200 is provided with a motor controller, which may be, for example, a switch or button operated by a user, or may be an automatic controller of a manipulator connected to the sled 203, so that when the user starts to move the sled 203, the motor controller turns on the motor 30, thereby causing the rigid inner hollow needle member 213 to start rotating, so that the rigid inner hollow needle member 213 rotates during the entire sample acquisition process.

[0302] After the sample has been acquired, the rigid inner hollow needle 213 is retracted into the rigid outer hollow needle 214 and the manipulation unit 200 is moved so that the rigid inner hollow needle 213 and the rigid outer hollow needle 214 are moved out of the tissue being sampled.

[0303] The interface section 213e of the rigid inner hollow needle member 213 may be provided with a plunger or the like capable of closing the proximal end of the rigid inner hollow needle member 213. By providing such a plunger, the air in the rigid inner hollow needle member 213 is trapped between the plunger at the proximal end and the tissue at the distal end, and the air will form an air cushion, thereby preventing excess tissue from accumulating in the rigid inner hollow needle member 213. Alternatively, such a plunger may be replaced by a mechanical blocking member positioned in the rigid inner hollow needle member 213. Such a mechanical blocking member is preferably inserted from the proximal end of the rigid inner hollow needle member 213. The mechanical blocking member may, but need not necessarily, provide an airtight or partially airtight connection with the inner side of the rigid inner hollow needle member 213. It may be noted that the provision of an air plunger or a mechanical blocking member is not limited to Figure 23 to Figure 26a to Figure 26b Design of biopsy instrument shown. The concept of having an air plunger or mechanical blocking member applies to all biopsy instruments disclosed.

[0304] During insertion, the blocking member may be positioned such that it blocks or closes the mouth of the rigid inner hollow needle 213 or the mouth of the inner elongated hollow tubular member 213 .

[0305] exist Fig. 27 In the invention, a variant of the biopsy instrument 1 is disclosed, which is configured to be similar to that in Figure 1a Unless clearly contradicted by the following disclosure, the biopsy instrument 1 and the kit are discussed above, especially with reference to Figures 1a to 22 Type.

[0306] The biopsy instrument 1 comprises a steering unit 30 including a motor 31. Fig. 27 In the embodiment disclosed in , the steering unit 30 is a separate box configured to be positioned on a shelf or the like. The steering unit 30 may house a power source and / or may be connected to a power source. The steering unit 30 may, for example, include a battery and / or may be connected to a power source (mains) 38.

[0307] The biopsy instrument 1 includes a telescoping mechanism. In this embodiment, the telescoping mechanism is connected to the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14 so that from the user's perspective, they are an integral component that is used as a single component and is typically also provided as a single component. Alternatively, the telescoping mechanism can be a separate component that can be connected to the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14.

[0308] The telescopic mechanism may for example be a reference Figures 18 to 22 The telescopic mechanism 100 disclosed in detail. Fig. 27 In the telescopic mechanism, Figures 28 to 30 The telescopic mechanism 101 is provided at its distal end with a connector 111, through which the telescopic mechanism 101 is configured to be fixedly connected to the insertion opening 41a of the endoscope.

[0309] The telescopic mechanism 101 is provided at its proximal end with a connector 15 configured to connect the base member 10 to the motor 31. Fig. 27 In the illustrated embodiment, the motor 31 is connected to the connector 15 via a drive wire 39. The drive wire 39 is preferably flexible. The drive wire 39 includes an inner drive wire 39i that transmits rotation and torque from the motor 31 to the base member 10 and an outer shell 39c that is stationary relative to the manipulation unit 30 and relative to the handle 102 of the telescopic mechanism 101. In addition to flexibility, the use of wire as an element for transmitting the rotation and torque of the motor has an advantage in that the wire is reliable, and if even if the wire is about to break, there will be a significant change in the performance of the wire before it breaks.

[0310] The telescoping mechanism 90, 100, 101 is provided at its proximal end with a connector 15, by which the connector 39e of the drive wire 39 is connected to the telescoping mechanism 90, 100, 101. The connector 15 of the telescoping mechanism 90, 100, 101 and / or the connector 39e of the drive wire 39 is provided with a locking mechanism 15a. The locking mechanism 15a allows the connectors 15, 39e to be connected to each other only by relative movement toward each other along the central axis A, but prevents the connectors 15, 39e from being disconnected by relative movement away from each other until the locking mechanism 15a has been released. Alternatively, this may be in the form of a bayonet connection or the like, in which the connector 39e is fitted with a recess that is twisted into place and locked in place until it is twisted in the opposite direction to be released.

[0311] The manipulation unit 30 is provided with a connector 30f, and the rotation ω and torque T from the motor 31 can be applied to the drive wire 39 through the drive wire 39 having a connector 39f at its proximal end, and the connector 39f of the drive wire 39 is configured to be connected to the connector 30f of the manipulation unit 30. The connector 30f of the manipulation unit 30 and / or the connector 39f of the drive wire 39 is provided with a locking mechanism 39g. The locking mechanism 39g allows the connectors 39f, 30f to be connected to each other only by relative movement toward each other along the central axis A, but prevents the connectors (39f, 30f) from being disconnected by relative movement away from each other until the locking mechanism (39g) has been released.

[0312] refer to Figures 28 to 30 , the telescoping mechanism 101 includes a handle 102. The handle 102 is connected to the base member 10 so that the base member 10 can rotate relative to the handle 102. The handle 102 is connected to the base member 10 so that when the handle 102 translates along the geometric axis A, the base member 10 will also translate along the geometric axis A. Preferably, the base member 10 is translationally coupled to the handle 102 so that translational movement of the handle 102 relative to the connector 111 along the geometric axis A provides a corresponding translational movement, and more preferably the same translational movement, of the base member 10 relative to the connector 111.

[0313] The handle 102 also includes a connection to the drive wire 39, such that the inner drive wire 39i can transmit rotation and torque from the motor 31 to the base member 10, and the housing 39c is stationary relative to the handle 102. The outer surface 39d of the drive wire 39, such as formed by the housing 39c, is formed of a polymer-based material or a flexible coating, wherein the polymer-based material is preferably an elastomeric material or a plastic material, wherein the polymer-based material or the flexible coating forms a low friction and non-adhesive surface.

[0314] The telescopic mechanism 101 further includes an intermediate component 103. The intermediate component 103 may also be referred to as a base member adjuster. The handle 102 is movable translationally relative to the intermediate component 103. Fig.29 As shown, the handle 102 is hollow and can receive the intermediate component 103. The intermediate component 103 is slidably received in the handle 102. Figure 27 to Figure 29 , the intermediate part 103 and the handle 102 are shown in an extended position; extended in such a way that the intermediate part 103 extends a maximum distance beyond the handle 102.

[0315] exist Fig.30, the intermediate component 103 is received in the handle 102. Since the handle 102 has moved closer to the connector 111 due to the intermediate component 103 being received in the handle 102, the base member 10 connected to the handle 102 has moved in the distal direction or forward direction relative to the connector 111. Therefore, the movement of the handle 102 toward the connector 111 relative to the intermediate component 103 causes the base component 10 to move, so that the base component 10 is advanced relative to the endoscope 40, and optionally also relative to the outer sheath 14.

[0316] The telescoping mechanism 101 further includes an adjustment member 104. The adjustment member 104 is slidably received on the intermediate component 103 so that the adjustment member 104 can slide relative to the intermediate component 103 along the central geometric axis A. The adjustment member 104 is provided with a locking member 104a, which is configured to lock the adjustment member 104 at different positions along the central geometric axis A relative to the intermediate component 103. The handle 102 is configured to receive the intermediate component 103 until the handle 102 abuts the adjustment member 104. Thus, a mechanism is provided that allows an operator to move the base member 10 while still controlling the maximum distance that the base member 10 can be advanced.

[0317] exist Fig.28 In the embodiment shown in FIG. 1 , the adjustment member 104 is in its most forward position, ie in a position where the handle 102 can move a maximum distance relative to the intermediate part 103 until the handle 102 abuts the adjustment member 104 .

[0318] The telescoping mechanism 101 further includes an end member 105. The end member 105 may also be referred to as an outer elongated hollow tubular member adjuster.

[0319] The end member 105 is translationally movable relative to the middle member 103. Fig.29 As shown, the middle part 103 is hollow and can receive the end part 105. The end part 105 is slidably received in the middle part 103. Figure 27 to Figure 29 , the middle part 103 and the end part 105 are shown in an extended position; extended in such a way that the end part 105 extends a maximum distance outside the middle part 103.

[0320] exist Fig.30 , the end part 105 is received in the intermediate part 103 , which results in the intermediate part 103 having been moved closer to the connector 111 .

[0321] The intermediate component 103 is connected to the outer elongate hollow tubular member 14 such that when the intermediate component 103 translates along the geometric axis A, the outer elongate hollow tubular member 14 will also translate along the geometric axis A. Preferably, the outer elongate hollow tubular member 14 is translationally coupled to the intermediate component 103 such that translational movement of the intermediate component 103 relative to the connector 111 along the geometric axis A provides a corresponding translational movement of the outer elongate hollow tubular member 14 relative to the connector 111, and more preferably, provides the same translational movement of the outer elongate hollow tubular member 14 relative to the connector 111. The end component 105 is provided with a passage 107 extending through the end component 105 along the central geometric axis A, the passage 107 allowing the outer elongate hollow member 14 to slidably extend through the end component 105.

[0322] Thus, when the end component 105 is received in the intermediate component 103, the outer elongate hollow tubular member 14 has already moved in a distal or forward direction relative to the connector 111. Thus, movement of the intermediate component 103 relative to the end component 105 toward the connector 111 causes the outer elongate hollow tubular member 14 to move, such that the outer elongate hollow tubular member 14 is advanced relative to the endoscope 40.

[0323] The telescopic mechanism 101 further includes an adjusting member 106 .

[0324] The adjustment member 106 may be slidably received on the end component 105 so that the adjustment member 106 may slide relative to the end component 105 along the central geometric axis A. The adjustment member 106 is provided with a locking member 106a configured to lock the adjustment member 106 at different positions along the central geometric axis A relative to the intermediate member 103.

[0325] In one variant, the intermediate part 103 is configured to receive the end part 105, wherein the adjustment member 106 is fixedly connected to the intermediate part 103, such as Fig.30 Thus, a mechanism is provided for locking the intermediate component 103 and the end component 105 in different relative positions, thereby also locking the outer elongate hollow tubular member 14 relative to the connector 111 and, in turn, the outer elongate hollow tubular member 14 relative to the endoscope 40.

[0326] In one variation, the intermediate member 103 is configured to receive the end member 105 until the intermediate member 103 abuts the adjustment member 106. Thus, a mechanism is provided for allowing an operator to move the outer elongated hollow tubular member 14 while still controlling the maximum distance that the outer elongated hollow tubular member 14 can be advanced. In this variation, the adjustment member 106 is separate from the intermediate member 103.

[0327] exist Figures 17 to 22 and Figures 27 to 30 In the embodiment of the telescoping mechanism disclosed in , a drive (such as a drive wire) is aligned with the base member 10 .

[0328] However, in Figure 31 to Figure 32 In the invention, a variation is disclosed in which a drive (such as a drive wire 39) is connected to the base member 10 offset. This allows the base member 10 to extend all the way through the telescoping mechanism so that it is accessible at the proximal end of the telescoping mechanism. This may be useful, for example, for the application of negative pressure. In this case, the base member 10 preferably includes an inner hollow elongated tubular member 13, which is preferably liquid-tight or gas-tight so that negative pressure can be applied through a connector 108 at the proximal end of the telescoping mechanism.

[0329] The handle 102 is connected to the base member 10 so that the base member 10 can rotate relative to the handle 102. The handle 102 is connected to the base member 10 so that when the handle 102 translates along the geometric axis A, the base member 10 will also translate along the geometric axis A. Preferably, the base member 10 is translationally coupled to the handle 102 so that translational movement of the handle 102 along the geometric axis A relative to the connector 111 provides a corresponding translational movement of the base member 10 relative to the connector 111, and more preferably provides the same translational movement of the base member 10 relative to the connector 111.

[0330] The handle 102 also includes a connection to the drive wire 39 so that the inner drive wire 39i can transmit rotation and torque from the motor 31 to the base member 10 and so that the housing 39c is stationary relative to the handle 102. In this variation, the handle 102 also includes a gear mechanism 109 connected between the connection to the drive wire 39 and the base member 10 so that the drive wire 39 is connected offset relative to the central geometric axis A.

[0331] It can also be noted that different variations of the biopsy instrument 1 can also be used for other purposes. Whether the inner hollow elongated tubular member 13 is rigid or flexible, it can be used as an introduction channel for introducing a guide wire. Whether the outer hollow elongated tubular member 14 is rigid or flexible, it can be used as an introduction channel for introducing a guide wire. The guide wire can be used, for example, to insert a stent, a balloon, a camera, an injection tube or the like. The guide wire can also be used to insert a marker, such as a marker visible on an X-ray image. In this case, the biopsy instrument 1 is typically used according to the following: first, the instrument is inserted into the tissue and a sample is optionally also obtained; thereafter, one of the elongated hollow tubular members 13, 14 is optionally completely removed (if a sample has been obtained, the inner hollow elongated tubular member 13 is removed so that the sample can be harvested); thereafter, a guide wire is inserted through the part of the biopsy instrument 1 that is still inserted in the intended position; thereafter, all parts of the biopsy instrument are retracted while the guide wire remains extended to the intended position; thereafter, a stent, a balloon, a marker are inserted or activated; and finally the guide wire is also retracted.

Claims

1. A kit of parts, comprising: Biopsy instruments, a steering unit, the steering unit comprising a motor, drive lines, and Telescopic mechanism, The biopsy instrument comprises: a base member extending from a proximal end to a distal end along a central geometric axis, wherein the distal portion of the base member is shaped as an elongated hollow tube, the elongated hollow tube at the distal end of the base member being provided with a distally facing circular cutting edge, the distally facing circular cutting edge defining a mouth of the distal end of the elongated hollow tube, and the elongated hollow tube being intended to be at least partially inserted into a tissue from which a biopsy is to be obtained, wherein the base member is capable of transmitting force along the central geometric axis so that movement of the proximal end of the base member along the central geometric axis is transmitted into movement of the distal end of the base member along the central geometric axis, and the base member is capable of transmitting torque around the central geometric axis so that rotation and torque around the central geometric axis applied by the motor at the proximal end of the base member are transmitted from the proximal end of the base member to the distal end of the base member, thereby causing the distal end of the base member to rotate around the central geometric axis, wherein the telescopic mechanism is configured to be connected to the proximal end of the biopsy instrument or to form a proximal part of the biopsy instrument, wherein the telescoping mechanism is configured to be connected to the manipulation unit via the drive wire, so that the proximal end of the base member is configured to be connected to the motor, so that rotation and torque can be applied by the motor to the proximal end of the base member and transmitted by the base member to the elongated hollow tube at the distal end of the base member, The biopsy instrument further comprises: an outer elongated hollow tubular member extending from a proximal end along a central geometric axis to a distal end, wherein the base member is disposed within the outer elongated hollow tubular member and is independently rotationally and translationally movable relative to the outer elongated hollow tubular member, wherein the elongated hollow tube can be advanced beyond the distal end of the outer elongated hollow tubular member and can be retracted into the outer elongated hollow tubular member by movement of the proximal end of the base member along the central geometric axis, and the elongated hollow tube can be rotated about the central geometric axis within and relative to the outer elongated hollow tubular member by the motor applying rotation and torque at the proximal end of the base member, and Wherein the motor is configured to provide rotation of the elongated hollow tube about the central geometric axis within and relative to the outer elongated hollow tubular member at a certain rotational speed by applying rotation and torque to the proximal end of the base member when the elongated hollow tube is advanced beyond the distal end of the outer elongated hollow tubular member and retracted into the outer elongated hollow tubular member, the rotational speed being at least 13,000 rpm, the base member being flexible and the outer elongated hollow tubular member being flexible.

2. The kit of parts according to claim 1, wherein: The motor is configured to provide rotation of the elongated hollow tube about the central geometric axis by applying rotation and torque to the proximal end of the base member at a rotational speed between 13,000 rpm and 25,000 rpm as the elongated hollow tube is advanced and retracted.

3. The kit of parts according to claim 1, wherein: The telescopic mechanism is provided with a connector at its distal end, and the telescopic mechanism is constructed to be fixedly connected to the insertion opening of the endoscope through the connector, wherein the connector can rotate around the central geometric axis relative to the telescopic mechanism, thereby the telescopic mechanism can rotate around the central geometric axis relative to the insertion opening of the endoscope.

4. The kit of parts according to claim 1, wherein: The telescopic mechanism is provided with a connector at its proximal end, through which the connector of the telescopic mechanism at its proximal end is connected to the telescopic mechanism, wherein the connector of the telescopic mechanism and / or the connector of the drive wire is provided with a locking mechanism, wherein the locking mechanism allows the connectors to be connected to each other only by relative movement toward each other along a central axis, but prevents the connectors from being disconnected by relative movement away from each other until the locking mechanism has been released.

5. The kit of parts according to claim 1, wherein: The steering unit is provided with a connector, via which the rotation and torque from the motor can be applied to the drive wire by the drive wire having a connector at a proximal end of the drive wire, the connector at the proximal end of the drive wire being configured to be connected to the connector of the steering unit, wherein the connector of the steering unit and / or the connector of the drive wire is provided with a locking mechanism, wherein the locking mechanism allows the connectors to be connected to each other only by relative movement toward each other along a central axis, but prevents the connectors from being disconnected by relative movement away from each other until the locking mechanism has been released.

6. The kit of parts according to claim 1, wherein: The outer surface of the drive wire is formed of a polymer-based material or a flexible coating, wherein the polymer-based material or the flexible coating forms a low-friction and non-adhesive surface.

7. The kit of parts according to claim 1, wherein: The inner or outer surface of the sample acquisition portion of the base member is liquid impermeable.

8. The kit of parts according to claim 1, wherein: The elongated hollow tube has a hollow elongated tubular sample acquisition portion at the distal portion of the elongated hollow tube, the sample acquisition portion having a smooth inner surface, wherein the smoothness of the smooth inner surface is such that when a reference biopsy is to be obtained, the cutting edge and the distal end of the elongated hollow tube are configured to be pushed into the tissue along the central geometric axis while being driven by a motor at its proximal end to rotate at a rotational speed of at least 13,000 rpm, and thereby cut the core of the tissue, the core of the tissue entering the sample acquisition portion of the elongated hollow tube through the mouth due to the advancement of the elongated hollow tube relative to the elongated hollow tube, wherein the circumferential outer surface of the core at least partially abuts the smooth inner surface of the sample acquisition portion, thereafter, the elongated hollow tube is driven by a motor at its proximal end to rotate at a rotational speed of at least 13,000 rpm While rotating at a rotational speed of rpm, the elongated hollow tube is retracted from the tissue, whereby the core of the tissue is detached from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by an adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, the adhesion force holding the core in the sample acquisition portion having the smooth inner surface.

9. The kit of parts according to claim 8, wherein: The distally facing circular cutting edge is shaped, and the smooth inner surface is connected to the cutting edge, such that the smooth inner surface extends to a distal-most portion of the cutting edge as viewed along the central geometric axis.

10. The kit of parts according to claim 8, wherein: When the smooth inner surface is formed of steel such as medical grade stainless steel, the surface roughness of the smooth inner surface has an Ra value of less than 1.5 μm, and when the smooth inner surface is formed of a polymer-based material, the surface roughness of the smooth inner surface has an Ra value of less than 6 μm.

11. The kit of parts according to claim 8, wherein: The smooth inner surface is formed from a polymer-based material.

12. The kit of parts according to claim 1, wherein: The base member includes an inner elongate hollow tubular member extending from the proximal end of the base member to the distal end of the base member.

13. The kit of parts according to claim 12, wherein: A polymer-based material forming a smooth inner surface is provided as a film, the polymer-based material is inserted into the inner elongated hollow tubular member and attached to the inner surface of the inner elongated hollow tubular member, wherein the smooth inner surface is smooth enough that when a reference biopsy is to be obtained, the cutting edge and the distal end of the elongated hollow tube are configured to be pushed into the tissue along the central geometric axis while being driven by a motor at its proximal end to rotate at a rotational speed of at least 13,000 rpm, and thereby cut a core of the tissue, the core of the tissue passing through the mouth relative to the elongated hollow tube into the sample acquisition portion of the elongated hollow tube due to the advancement of the elongated hollow tube, wherein the circumferential outer surface of the core at least partially abuts the smooth inner surface of the sample acquisition portion, thereafter the elongated hollow tube is driven by a motor at its proximal end to rotate at a rotational speed of at least 13,000 rpm. While rotating at a rotational speed of rpm, the elongated hollow tube is retracted from the tissue, whereby the core of the tissue is detached from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by an adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, the adhesion force holding the core in the sample acquisition portion having the smooth inner surface.

14. The kit of parts according to claim 12, wherein: The inner elongated hollow tubular member includes a hollow metal wire rope, which is capable of transmitting force along the central geometric axis so that the movement of the proximal end along the central geometric axis is transmitted to the movement of the distal end along the central geometric axis, and the hollow metal wire rope is capable of transmitting torque around the central geometric axis so that the rotation and torque around the central geometric axis applied by the motor at the proximal end are transmitted from the proximal end to the distal end, thereby causing the distal end to rotate around the central geometric axis.

15. The kit of parts according to claim 12, wherein: The inner elongated hollow tubular member is provided with the distally facing circular cutting edge at its distal end.

16. The kit of parts according to claim 1, wherein: The outer elongated hollow tubular member includes a hollow metal wire.

17. The kit of parts according to claim 1, wherein: The base member has at its proximal end a connector for connection to a motor, the connector being capable of transmitting the movement along the central geometric axis as well as the rotation and the torque.

18. A kit of parts according to any one of the preceding claims, wherein: The core of the tissue is separated from the tissue by shear forces and / or stretching forces.

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